Paullee
4年前
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01/14 LIGAND PHARMACEUTICALS INC : Termination of a Material Definitive Agreement (form 8-K)
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LIGAND PHARMACEUTICALS INC : Termination of a Material Definitive Agreement (form 8-K)
01/14/2022 | 04:25pm EST
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Item 1.02 Termination of a Material Definitive Agreement
As previously disclosed, on September 30, 2020, Ligand Pharmaceuticals Incorporated (the "Company") and American Stock Transfer & Trust Company, LLC ("AST") entered into a contingent value rights agreement (the "CVR Agreement") in connection with the Company's acquisition of Pfenex, Inc ("Pfenex"). Pursuant to the terms of the CVR Agreement, former equityholders of Pfenex received one non-transferrable contractual right entitling such holder to receive an amount in cash in the event that Pfenex's teriparatide injection product received notice from the U.S. Food and Drug Administration that such product is therapeutically equivalent with respect to FORTEO® (teriparatide injection) on or before December 31, 2021 (the "Expiration Date"). The FDA did not provide notice of such event prior to the Expiration Date and as a result, the CVRs expired without payment.
On January 14, 2022, the Company delivered written notice to AST to terminate the CVR Agreement, effective immediately. A copy of the CVR Agreement was filed as Exhibit 2.5 to the Company's Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2020, filed with the Securities and Exchange Commission on November 6, 2020. The description of the CVR Agreement does not purport to be complete and is qualified in its entirety by the full text of the CVR Agreement and is incorporated herein by reference.
Paullee
6年前
Pfenex : Adalvo announces positive CHMP opinion for Livogivatm (Teriparatide injection)
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06/29/2020 | 10:54am EDT
New commercialization agreement in Latin America announced with a large, multinational pharmaceutical firm.
Adalvo today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending marketing authorization for Livogiva(TM) (teriparatide injection), previously referred to as PF708, a biosimilar product candidate to the reference medicine Forsteo® (teriparatide injection) indicated for use in postmenopausal women with osteoporosis who are at high risk of having bone fractures. The CHMP's recommendation will now be considered by the European Commission.
Adalvo (on behalf of Alvogen) and Pfenex enterered into an exclusive agreement in June 2018, granting Adalvo/Alvogen exclusive rights to commercialize Pfenex's lead drug candidate, PF708, a teriparatide therapeutic equivalent candidate to Eli Lilly & Company's Forteo®, in the United States.
"We are excited by the potential market opportunity that Livogiva, if granted marketing authorization by the European Commission, may offer as a biosimilar to Forsteo® and the potential to enhance patient access to this important product. The marketing authorization, if granted, would represent our first marketing authorization for a biosimilar productapproval and underlines significant market access capabilities for Adalvo that deals with complex product filings and registrations in global markets. We are also pleased to announce our partnership with a leading commercial player in the LATAM region to commercialize PF708, upon granting of applicable marketing authorizations, to potentially offer an alternative solution to patients in additional countries."
Anil Okay, General Manager of Adalvo
If the European Commission affirms the CHMP opinion, it will grant a centralized conditional marketing authorization, with unified labeling that is valid in the 27 countries that are members of the European Union, as well as European Economic Area members, Iceland, Liechtenstein and Norway. The version of Livogiva that is approved for marketing in the United States is Teriparatide Injection (previously referred to as PF708, as well as Bonsity), which the U.S. Food and Drug Administration continues to evaluate for therapeutic equivalence to its reference drug Forteo®.
"Both the positive opinion from CHMP and the new commercialization agreement in Latin America represent important progress toward the global licensure and commercialization of PF708, which has the potential to improve patient access to this important drug throughout the world. Our work would not have been possible without the efforts of our global commercialization partner, Adalvo/Alvogen"
Eef Schimmelpennink, Chief Executive Officer of Pfenex
PF708 is a biosimilar product candidate to Forsteo®, which achieved $253 million in sales in the E.U. and $1.4 billion globally in 2019.
About PF708
PF708 was approved in the U.S. under the 505(b)(2) regulatory pathway, with Forteo® (teriparatide injection) as the reference drug, and commercially launched as Teriparatide Injection. Teriparatide Injection is indicated, among other uses, for the treatment of osteoporosis in certain patients at high risk for fracture. Pursuant to the Development and License Agreement with Alvogen, Pfenex has transferred the new drug application (NDA) for Teriparatide Injection to Alvogen, and Alvogen is responsible for manufacturing and commercializing the product in the U.S. and for fulfilling all regulatory requirements associated with maintaining the Teriparatide Injection NDA. Alvogen also has exclusive rights to commercialize and manufacture PF708 in the European Union (EU), certain countries in the Middle East and North Africa (MENA), and the Rest of World (ROW) territories (the latter defined as all countries outside of the EU, U.S. and MENA, excluding Mainland China, Hong Kong, Singapore, Malaysia and Thailand). A marketing authorization application for PF708, which will be branded in Europe as Livogiva, has been filed and accepted with the EMA using the biosimilar pathway with Forsteo® as the reference medicinal product, and the CHMP has issued a positive opinion; and a marketing authorization application for PF708 has been filed with the Kingdom of Saudi Arabia's SFDA.
Forteo® and Forsteo® are approved and marketed by Eli Lilly and Company for the treatment of osteoporosis in certain patients with a high risk for fracture.
About Adalvo
Adalvo is a global pharmaceutical company with a declared purpose to make a difference for patients around the world driven by our smart collaboration network and commitment to deliver highest quality differentiated products and services to our partners. Our business is fueled by our passion for relentless commitment to the customer network we serve. No half measures - we are always on target.
At Adalvo, we know that our customers like to be bigger, better and smarter in the dynamic pharmaceutical sector. That's why our approach is unique, customized and challenges the status quo that helps our partners achieve their business goals. We pride ourselves on helping our customers reach their goals - whether that's increasing revenues, pushing into new markets - we always play for the high score and to be on target for the partners we serve. While our clients are our highest priority, we're also committed to our purpose and our mission to accelerate the growth and development of our employees and local communities. We are Adalvo - a leading B2B pharmaceutical company.
Paullee
6年前
Pfenex Announces U.S. Commercial Launch of Teriparatide Injection
•
Pfenex’s commercialization partner Alvogen will lead launch and commercialization efforts in the United States
•
The first FDA-approved teriparatide with Forteo® 1-3 as the reference drug
SAN DIEGO, June 12, 2020 —Pfenex Inc. (NYSE American: PFNX) today announced that its commercialization partner, Alvogen, has launched Teriparatide Injection in the United States. Teriparatide Injection (also referred to as PF708 and Bonsity™) is a prescription medicine approved for several uses, including in postmenopausal women with osteoporosis who are at high risk for having bone fractures.
Teriparatide Injection is the first teriparatide product since Forteo® (teriparatide injection)1-3 approved for this use. The Alvogen product is pharmaceutically equivalent to Forteo (that is, has the same active ingredient in the same strength, dosage form and route of administration) and has been shown to have comparable bioavailability. These characteristics allowed the product to be approved under a 505(b)(2) NDA for which Forteo was the reference drug. It may provide a lower-cost teriparatide option4 for increasing bone density in patients at high risk for fracture5, and is FDA-approved for the same indications as Forteo, which means it can be used for the same patients as Forteo, including new patients and those currently responding to treatment1,2.
“We are pleased to announce the availability of Teriparatide Injection in pharmacies - the first new FDA-approved teriparatide, which provides an alternative to Forteo,” said Pfenex CEO Eef Schimmelpennink. “As the first Pfenex-developed product to reach the market, this marks an important milestone for the company and delivers on the promise of the Pfenex Expression Technology platform.”
“Alvogen is excited to bring this critical product to patients in need of a lower-cost alternative to Forteo,” said Lisa Graver, President of Alvogen, Inc. “We are happy to partner with Pfenex to bring this product to market.”
1Teriparatide Injection prescribing information: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1b007339-dd0d-f019-5e0a-9b1b0f75011c. Morristown, NJ: Alvogen, Inc.; 2019.
2Forteo prescribing information: https://uspl.lilly.com/forteo/forteo.html#pi. Indianapolis, IN: Eli Lilly and Company; 2012.
3Data on File.
4 Lower WAC and AWP compared to Forteo® (teriparatide injection).
5High risk for fracture is defined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy.
About Teriparatide Injection
Teriparatide Injection (https://www.alvogenteriparatide.com/) is a medication designed to assist in building new bone and is comprised of protein similar to one naturally produced by the body. It has also been shown to help increase bone strength.1 Teriparatide Injection helps to reinforce bone by replacing—and replenishing—that which has been lost due to osteoporosis. Postmenopausal women with osteoporosis, who were at high risk for fracture, experienced significantly increased bone mineral density in the spine, after taking Teriparatide Injection with calcium and vitamin D. These results were demonstrated at three months, and throughout the treatment period. The risk of new spine fractures was reduced by approximately two thirds; the risk of new fractures in other bones—including the ankle/foot, hip, upper arm, pelvis, ribs and wrist—was cut in half.2
Teriparatide Injection is contraindicated for those patients with a hypersensitivity to teriparatide or to any of its excipients. Reactions have included angioedema and anaphylaxis. (Prescribing Information: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1b007339-dd0d-f019-5e0a-9b1b0f75011c)
As part of drug testing, teriparatide, the active ingredient in Teriparatide Injection, was given to rats for a significant part of their lifetime. In these studies, teriparatide caused some rats to develop osteosarcoma, a bone cancer. Osteosarcoma in humans is a serious but very rare cancer. Osteosarcoma occurs in about four out of every million older adults each year. It is not known if humans treated with Teriparatide Injection also have a higher chance of getting osteosarcoma. Other side effects may include nausea, dizziness, leg cramps and joint aches. Injection site reactions include redness, swelling, pain, itching, a few drops of blood and bruising. (Prescribing Information: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1b007339-dd0d-f019-5e0a-9b1b0f75011c)
1Only proven in postmenopausal women with osteoporosis.
2This clinical study involved 1,637 postmenopausal women with osteoporosis, of whom 90% had a spine fracture. 541 women took a daily 20-mcg dose of Teriparatide Injection; 544 took a placebo for a median time of 19 months, and a maximum of 24 months. All women took calcium and vitamin D daily.
About Osteoporosis
Osteoporotic fractures create a significant healthcare burden. An estimated two million osteoporotic fractures occur annually in the United States, and this number is projected to grow to three million by 2025. Osteoporosis is a disease of the bone that makes a person’s bones weak and more likely to break. Approximately 10 million Americans have osteoporosis and another 44 million have low bone mass placing them at increased risk for osteoporosis. The annual incidence of osteoporotic fractures in women is higher than that of stroke, heart attack and breast cancer combined. A woman’s risk of fracture is equal to her combined risk of breast, uterine and ovarian cancer.
About Pfenex Inc.
Pfenex is a development and licensing biotechnology company focused on leveraging its proprietary protein production platform, Pfenex Expression Technology®, to develop next generation and novel protein therapeutics to meaningfully improve existing therapies and create novel therapies for some of the biological targets linked to critical diseases still waiting to
successfully be addressed. Using the patented Pfenex Expression Technology platform, Pfenex has created a broad pipeline that is diversified across multiple assets, including U.S. Food and Drug Administration (FDA) approved, next generation and novel biopharmaceutical products. Pfenex’s lead product is Teriparatide Injection (previously referred to as PF708 and Bonsity™), a therapeutic equivalent candidate to Forteo® (teriparatide injection). Teriparatide Injection has been commercialized in the U.S. for the treatment of osteoporosis in certain patients at high risk for fracture, and marketing authorization applications are pending in other jurisdictions. In addition, Pfenex is developing hematologic oncology products in collaboration with Jazz Pharmaceuticals, including PF743, a recombinant Erwinia asparaginase, and PF745, a half-life extended recombinant Erwinia asparaginase. Pfenex also uses its Pfenex Expression Technology platform to produce CRM197, a diphtheria toxoid carrier protein for use in prophylactic and therapeutic vaccines.
Pfenex investors and others should note that Pfenex announces material information to the public about Pfenex through a variety of means, including its website (http://www.pfenex.com/), its investor relations website (http://pfenex.investorroom.com/), press releases, SEC filings, public conference calls, corporate Twitter account (https://twitter.com/pfenex), Facebook page (https://www.facebook.com/Pfenex-Inc-105908276167776/timeline/), and LinkedIn page (https://www.linkedin.com/company/pfenex-inc) in order to achieve broad, non-exclusionary distribution of information to the public and to comply with its disclosure obligations under Regulation FD. Pfenex encourages its investors and others to monitor and review the information Pfenex makes public in these locations as such information could be deemed to be material information. Please note that this list may be updated from time to time.
Paullee
6年前
More color on delay
Pfenex Receives General Advice Letter for PF708
Pfenex Inc. (PFNX) reported that its commercialization partner for PF708, Alvogen Malta Operations Ltd., has received a General Advice Letter from the FDA for the submission of additional comparative use human factors data. The letter also emphasized that the data specifically from Forteo experienced users would be required before the determination of PF708 Therapeutic Equivalence. The application was already accompanied by comparative use human factors (CUHF) data from Forteo-experienced patients and caregivers.
Pfenex is working on PF708 in collaboration with Alvogen Malta Operations Ltd. The company stated that the FDA now requires the data from larger number of experienced subjects. However, the FDA has stated that it will continue with the assessment of data already provided with the application. The regulatory body also offered guidance to the company with regard to study methodology to be employed for generating additional data.
Eef Schimmelpennink, Chief Executive Officer of Pfenex, said, “We intend to work closely with Alvogen and the FDA to expeditiously move toward a solution addressing the Agency’s expressed views, so that we can submit additional data as soon as possible. Additionally, we will continue to support Alvogen with its commercial strategy planning in the U.S. while continuing to seek “A” therapeutic equivalence designation.”
Pfenex is a biotechnology firm which mainly focuses on leveraging the use of its proprietary protein production platform, Pfenex Expression Technology, for developing novel protein therapeutics. The company has a strong development pipeline, including drug candidates such as PF745 which is a half-life extended recombinant Erwinia asparaginase and PF743 which is a recombinant Erwinia asparaginase.
Thanks for reading. At the Total Pharma Tracker, we do more than follow biotech news. Using our IOMachine, our team of analysts work to be ahead of the curve.
Paullee
6年前
Serum Institute of India Private Limited has achieved World Health Organization (WHO) prequalification for PNEUMOSIL®, containing CRM197 produced in Pfenex Expression Technology
GlobeNewswire GlobeNewswire•January 8, 2020
SAN DIEGO, Jan. 08, 2020 (GLOBE NEWSWIRE) -- Pfenex Inc. (NYSE American: PFNX) today announced that Serum Institute of India Private Limited (Serum Institute) achieved World Health Organization (WHO) prequalification for Pneumosil, a 10-valent pneumococcal conjugate vaccine. Pneumosil contains the recombinant carrier protein CRM197 produced by Serum Institute under a license to the Pfenex Expression Technology®.
Under the agreement with Serum Institute, Pfenex is eligible to receive annual fees, milestone payments, and a tiered low single digit royalty based on net sales for all products developed by Serum Institute that use the CRM197 carrier protein produced via the Pfenex Expression Technology.
“Our partnership with Serum Institute continues to be successful. We are thrilled to have played a part in their mission to help ensure that children of low- and middle-income countries have access to lifesaving vaccines at a sustainable price,” said Eef Schimmelpennink, Chief Executive Officer of Pfenex.
“I am extremely pleased to see the WHO PQ of Pneumosil. This could help pave the way for saving lives by using a highly cost-effective Pneumococcal vaccine. For this vaccine, we have used Pfenex Expression Technology for the manufacturing of recombinant CRM197 (rCRM197) co-developed with Pfenex. I am also pleased to note that our next product in the pipeline which utilizes rCRM197 is also in late stage clinical development,” said Adar Poonawalla, Chief Executive Officer of Serum Institute of India.
Pneumosil covers over 71% invasive pneumococcal disease (IPD) causing serotypes, and targets the Indian Universal Immunization Programme and Asian, African and other countries under the Gavi Advanced Market Commitment (AMC).
A second product being developed by Serum Institute which also utilizes CRM197 as one of its carrier proteins and is subject to the Pfenex Expression Technology license is a thermostable Pentavalent Meningococcal Conjugate Vaccine (A, C, Y, W-135, X). This product is currently in a Phase 3 clinical study and is also targeted for developing countries.
About CRM197
Pfenex CRM197 is a non-toxic mutant of diphtheria toxin having a single amino acid substitution of glutamic acid to glycine at position 52. CRM197 is a well-defined protein and functions as a carrier for polysaccharides and haptens, making them immunogenic. It is utilized as a carrier protein in several approved conjugate vaccines for diseases such as Streptococcus pneumoniae, Haemophilus influenzae b and Neisseria meningitidis. Pfenex CRM197 is a recombinant, soluble form produced by the Pfenex Expression Technology® platform. CRM197 is currently being used by vaccine development focused pharmaceutical partners, including Merck and the Serum Institute of India Private Ltd., (SIIPL). In 2018, Merck announced that it had initiated multiple Phase 3 clinical studies of PCV-15 (V114), an investigational polyvalent conjugate vaccine for the prevention of pneumococcal disease. SIIPL who is developing a 10-valent pneumococcal conjugate vaccine, Pneumosil recently achieved World Health Organization Prequalification (PQ).
Paullee
6年前
And here's the reason
Pfenex Earns $15 Million Development Milestone Under its Development and License Agreement With Jazz Pharmaceuticals
GlobeNewswire GlobeNewswire•December 18, 2019
SAN DIEGO, Dec. 18, 2019 (GLOBE NEWSWIRE) -- Pfenex Inc. (NYSE American: PFNX) today announced that it has earned a $15 million development milestone under its development and license agreement with Jazz Pharmaceuticals plc. The milestone is associated with process development activities for PF745, a long-acting Erwinia asparaginase.
“We are very pleased with the rapid progression of the PF745 program and we believe the Jazz collaboration, overall, further validates the versatility of our proprietary protein expression platform and the quality of our development capabilities,” said Eef Schimmelpennink, Chief Executive Officer of Pfenex. “Additionally, we are excited about Jazz’s recent announcement that the lead product in our partnership, PF743 (JZP-458), is expected to begin recruiting patients into the pivotal Phase 2/3 clinical study as early as this month.”
Under the terms of the development and license agreement, Pfenex is eligible to receive an aggregate total of up to $224.5 million in development and sales milestones, of which $162.5 million is still eligible to be received by Pfenex, including up to $3.5 million for development milestones, $34 million in regulatory milestones and $125 million in sales milestones. Pfenex may also be eligible to receive tiered royalties based on worldwide sales of any products resulting from the collaboration.
Paullee
7年前
Pfenex Reports Positive Results for PF708 Comparative Use Human Factors Study
GlobeNewswire•October 14, 2019
Study results found that the FDA-approved PF708 product is noninferior to Forteo® based on a pre-specified statistical analysis of critical patient and caregiver tasks
Pfenex believes the study report completes the information package required by the FDA to evaluate the FDA-approved PF708 product for therapeutic equivalence
SAN DIEGO, Oct. 14, 2019 (GLOBE NEWSWIRE) -- Pfenex Inc. (NYSE American: PFNX) announced today it has successfully completed the PF708 comparative use human factors (HF) study and submitted the final study report to the FDA. The study found that the user interface of the FDA-approved PF708 product was noninferior to that of Forteo® for each critical user task evaluated in the study. Pfenex believes this submission completes the information package required by the FDA to evaluate the therapeutic equivalence of the PF708 product. Pfenex is seeking FDA designation of the recently-approved product as therapeutically equivalent (“A” rated) to Forteo, which would permit PF708 to be automatically substituted for Forteo in many states.
“We are very pleased with the outcome of the human factors study, which we believe demonstrates noninferiority between the user interfaces of our product and Forteo,” said Eef Schimmelpennink, Chief Executive Officer of Pfenex. “We look forward to the FDA’s review of the study report, along with the bioequivalence and pharmaceutical equivalence data in our recently approved NDA. We believe these results complete the information package required by the FDA to evaluate therapeutic equivalence of our PF708 product,” commented Mr. Schimmelpennink.
The comparative use HF study was a simulated use study intended to evaluate the effect of each product’s delivery device and user interface on critical task performance by untrained osteoporosis patients and caregivers. The study used a paired design of the FDA-approved PF708 and the Forteo products.
A total of 102 untrained participants, 52 osteoporosis patients and 50 caregivers, completed the study. For 67% (12 of 18) of critical tasks performed in the patient user group, and 83% (15 of 18) performed in the caregiver group, PF708 had fewer or equal user errors when compared to Forteo. Importantly, in each of the instances where PF708 had marginally higher user error rates (33% and 17 % of critical tasks among patients and caregivers, respectively), the magnitude of the differences was such that no error difference in either user group exceeded the predetermined maximum allowable difference. For these reasons, Pfenex believes the study data demonstrate that the user interface of the FDA-approved PF708 product is noninferior to that of Forteo. With submission of the final study report to FDA, the agency can begin its review of the relevant data to make a therapeutic equivalence determination.
About PF708
PF708 was approved in the U.S. under the 505(b)(2) regulatory pathway, with Forteo® (teriparatide injection) as the reference drug. The FDA-approved PF708 product is indicated for the treatment of osteoporosis in certain patients at high risk of fracture. Pursuant to the Development and License Agreement with Alvogen, Alvogen is responsible for commercializing and manufacturing PF708 in the U.S. and for fulfilling all regulatory requirements associated with maintaining the PF708 NDA. Alvogen also has exclusive rights to commercialize and manufacture PF708 in the EU, certain countries in the Middle East and North Africa (MENA), and the Rest of World (ROW) territories (the latter defined as all countries outside of the EU, U.S. and MENA, excluding Mainland China, Hong Kong, Singapore, Malaysia and Thailand). A marketing authorization application for PF708 has been filed and accepted with the EMA using the biosimilar pathway with Forsteo® as the reference medicinal product and has been filed with the Kingdom of Saudi Arabia's Saudi Food and Drug Authority (SFDA). Pursuant to the Development and License Agreement with NT Pharma Group Company Ltd. (NT Pharma) we granted an exclusive license to NT Pharma to commercialize PF708 in Mainland China, Hong Kong, Singapore, Malaysia and Thailand and a non-exclusive license to conduct development activities in such territories with respect to PF708. Forteo® and Forsteo® are approved and marketed by Eli Lilly companies for the treatment of osteoporosis in certain patients with a high risk of fracture. Forteo® and Forsteo® achieved $1.6 billion in global product sales in 2018.
About Pfenex Inc.
Pfenex is a development and licensing biotechnology company focused on leveraging its Pfenex Expression Technology® to develop and improve protein therapies for unmet patient needs. Using the patented Pfenex Expression Technology platform, Pfenex has created an advanced pipeline of potential therapeutic equivalents, vaccines, biologics and biosimilars. Pfenex’s lead product candidate is PF708, a therapeutic equivalent candidate to Forteo® (teriparatide injection). PF708 has been approved in the U.S. for the treatment of osteoporosis in certain patients at high risk of fracture, and marketing authorization applications are pending in other jurisdictions. In addition, Pfenex is developing hematology/oncology products in collaboration with Jazz Pharmaceuticals, including PF743, a recombinant crisantaspase, and PF745, a recombinant crisantaspase with half-life extension technology. Pfenex also uses its Pfenex Expression Technology platform to produce CRM197, a diphtheria toxoid carrier protein used in prophylactic and therapeutic vaccines.
Paullee
7年前
PFenex Provides Update for PF708 Outside the United States
GlobeNewswire•October 11, 2019
New Exclusive Commercialization Agreements in South Korea, Canada, and Israel
Submission of Marketing Authorization Application for PF708 in Saudi Arabia
Potential approval of PF708 in the EU as early as the second half of 2020
SAN DIEGO, Oct. 11, 2019 (GLOBE NEWSWIRE) -- Pfenex Inc. (NYSE American: PFNX) today announced that its partner Alvogen has entered into exclusive commercialization agreements for PF708 with PharmBio Korea in South Korea, JAMP Pharma in Canada and Kamada Ltd. in Israel. Furthermore, Alvogen’s partner in the Middle East and North Africa (MENA) region, SAJA, submitted a Marketing Authorization Application (MAA) to the Kingdom of Saudi Arabia's Saudi Food and Drug Authority (SFDA). Additionally, the accepted MAA for PF708 under review by the European Medicines Agency (EMA) continues to make progress and Pfenex believes that PF708 could be approved in the European Union (EU) as early as the second half of 2020, pending marketing authorization by the European Commission under the EU centralized procedure and other factors.
“The new commercialization agreements in South Korea, Canada, and Israel, the filing of the PF708 MAA with the Saudi Food and Drug Authority, and the progress on Alvogen’s submission in Europe are important milestones for the PF708 commercialization program,” said Eef Schimmelpennink, Chief Executive Officer of Pfenex. “These are just the latest steps forward in our global commercialization strategy for PF708 as we continue to build positive momentum with our commercial partner, Alvogen.”
Faysal Kalmoua, Executive Vice President of Alvogen’s Global Portfolio, added, “We are very pleased with the latest submissions for PF708 and new commercial agreements with our partners in Canada, South Korea and Israel. Through our strong marketing network and growing pipeline of biosimilars, we can continue to deliver on our mission to provide high quality, affordable healthcare for patients.”
Subject to applicable regulatory approvals, PF708 will be commercialized by PharmBio Korea in Korea, JAMP Pharma in Canada, and Kamada in Israel. Under the terms of the agreements, Alvogen will be responsible for overseeing the local activities through PharmBio Korea, JAMP Pharma and Kamada. Pfenex will be eligible to receive milestone payments and a percentage of net sales or transfer price.
PharmBio Korea was founded in 1999 by Mr. Bong-Kil Nam, its Chairman and CEO. With innovative marketing strategies and constructive partnerships, PharmBio Korea has developed a pipeline of innovative products and has licensed and marketed products in collaboration with pharmaceutical companies in the EU, Japan, and U.S.
JAMP Pharma is a private Canadian company that was established in 1988 in British Columbia. Its current headquarters is in Quebec. JAMP Pharma is a key player in the generic pharmaceutical industry and one of the fastest growing pharmaceutical companies in Canada.
Kamada Ltd. is a biopharmaceutical company specializing in the development, manufacture and marketing of proteins as pharmaceuticals. The Company's headquarters and laboratories are located in the park of Kiryat Weizmann Institute of Science in Rehovot, Israel.
About PF708
PF708 is approved in the U.S. under the 505(b)(2) regulatory pathway, with Forteo® (teriparatide injection) as the reference drug. The FDA-approved PF708 product is indicated for the treatment of osteoporosis in certain patients at high risk of fracture. Pursuant to the Development and License Agreement with Alvogen, Alvogen is responsible for commercializing and manufacturing PF708 in the U.S. and for fulfilling all regulatory requirements associated with maintaining the PF708 NDA. Alvogen also has exclusive rights to commercialize and manufacture PF708 in the EU, certain countries in the Middle East and North Africa (MENA), and the Rest of World (ROW) territories (the latter defined as all countries outside of the EU, U.S. and MENA, excluding Mainland China, Hong Kong, Singapore, Malaysia and Thailand). A marketing authorization application for PF708 has been filed and accepted with the EMA using the biosimilar pathway with Forsteo® as the reference medicinal product and has been filed with the Kingdom of Saudi Arabia's Saudi Food and Drug Authority (SFDA). Forteo® and Forsteo® are approved and marketed by Eli Lilly companies for the treatment of osteoporosis in certain patients with a high risk of fracture. Forteo® and Forsteo® achieved $1.6 billion in global product sales in 2018.
About Pfenex Inc.
Pfenex is a development and licensing biotechnology company focused on leveraging its Pfenex Expression Technology® to develop and improve protein therapies for unmet patient needs. Using the patented Pfenex Expression Technology platform, Pfenex has created an advanced pipeline of potential therapeutic equivalents, vaccines, biologics and biosimilars. Pfenex’s lead product candidate is PF708, a therapeutic equivalent candidate to Forteo® (teriparatide injection). PF708 has been approved in the U.S. for the treatment of osteoporosis in certain patients at high risk of fracture, and marketing authorization applications are pending in other jurisdictions. In addition, Pfenex is developing hematology/oncology products in collaboration with Jazz Pharmaceuticals, including PF743, a recombinant crisantaspase, and PF745, a recombinant crisantaspase with half-life extension technology. Pfenex also uses its Pfenex Expression Technology platform to produce CRM197, a diphtheria toxoid carrier protein used in prophylactic and therapeutic vaccines.
Pfenex investors and others should note that Pfenex announces material information to the public about Pfenex through a variety of means, including its website (http://www.pfenex.com/), its investor relations website (http://pfenex.investorroom.com/), press releases, SEC filings, public conference calls, corporate Twitter account (https://twitter.com/pfenex), Facebook page (https://www.facebook.com/Pfenex-Inc-105908276167776/timeline/), and LinkedIn page (https://www.linkedin.com/company/pfenex-inc) in order to achieve broad, non-exclusionary distribution of information to the public and to comply with its disclosure obligations under Regulation FD. Pfenex encourages its investors and others to monitor and review the information Pfenex makes public in these locations as such information could be deemed to be material information. Please note that this list may be updated from time to time.
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