|Pfizer Acquires Minority Interest in AM-Pharma; Secures Option to Acquire Company; FDA Panel Backs Vertex's Orkambi|
|By David Fowler|
|Tuesday, 12 May 2015 19:02|
Below is a look at some of the headlines for companies that made news in the healthcare sector on May 12, 2015.
Pfizer Inc. (NYSE: PFE) and AM-Pharma B.V., a privately held Dutch biopharmaceutical company focused on the development of recombinant human Alkaline Phosphatase (recAP ) for inflammatory diseases, announced Pfizer has acquired a minority equity interest in AM-Pharma and secured an exclusive option to acquire the remaining equity in the company. The option becomes exercisable upon completion of a Phase II trial of recAP in the treatment of Acute Kidney Injury (AKI) related to sepsis. There are no drugs currently approved for this condition and the only treatment option is dialysis and supportive care. Results from the current Phase II trial for recAP are expected in the second half of 2016.
Under the terms of the agreement, Pfizer has made an upfront payment of $87.5 million for the minority equity interest and exclusive option, with additional potential payments of up to $512.5 million upon option exercise and potential launch of any product that may result from this agreement. Other terms of the transaction were not disclosed.
“Pfizer is committed to advancing the science to address the high unmet medical need in Acute Kidney Injury” said Mikael Dolsten, M.D., Ph.D., President, Worldwide Research and Development at Pfizer. “Clinical data for recAP show the potential to uniquely address Acute Kidney Injury in the setting of sepsis, and we look forward to working with our partners at AM-Pharma as we aim to accelerate the development of recAP into a potential first-in-class treatment for patients.”
Erik van den Berg, CEO of AM-Pharma added: “This agreement is a significant step for AM-Pharma, and we welcome Pfizer as a shareholder and dedicated partner. This deal not only provides good shareholder value, but provides the next step in the development of recAP as a potential treatment for patients with Acute Kidney Injury and other inflammatory diseases.”
Ropes & Gray LLP and De Brauw Blackstone Westbroek N.V. acted as legal advisors to Pfizer, and Dechert LLP and Clifford Chance LLP acted as legal advisors to AM-Pharma.
Vertex Pharmaceuticals Inc.’s experimental cystic fibrosis treatment Orkambi won the backing of a Food and Drug Administration advisory committee on Tuesday, which voted 12 to 1 to recommend approval of the drug.
The FDA is expected to make a final decision on whether to approve Orkambi by July 5. The FDA isn’t required to follow the committee’s recommendation, but it usually does. The FDA advisory committee comprises 13 independent doctors, scientists, and consumer and patient representatives.
In clinical studies, the lung function of patients taking Orkambi improved by a range of 2.6 percentage points to 3 percentage points compared with that of patients receiving placebo. FDA officials called the drug’s effect “modest,” but said it was a statistically significant improvement compared with the lung-function declines experienced by patients receiving placebos.
Vertex officials, along with nearly 20 patients and doctors, told the advisory committee that Orkambi was a meaningful advance in treating cystic fibrosis, a progressive lung disease that often kills patients in their 20s. Jeff Masters, a cystic fibrosis patient in his 30s, said the drug had helped him gain weight, reduced his dependence on other medications and improved his quality of life.
Some committee members who voted to recommend approval said they were concerned that the drug’s benefit was relatively small on average, and that some patients actually experienced worsened lung function while taking the drug. Still, a majority of advisers concluded Orkambi’s potential benefits outweighed its risks in treating cystic fibrosis.
“This was a difficult vote for me,” said Elaine H. Morrato, an associate professor at the Colorado School of Public Health, who voted to recommend approval.
The advisory committee voted unanimously that the drug was safe. In clinical studies, a higher percentage of patients receiving Orkambi discontinued treatment or experienced liver-related serious adverse events than patients taking placebos, the FDA said. “The risks are small, or modest, and are all manageable with appropriate monitoring,” said Robert G. Castile, an advisory committee member and physician at Nationwide Children’s Hospital in Columbus, Ohio.
Shares of Vertex rose 7.2% to $133 in after-hours trading.
Agile Therapeutics, Inc. (Nasdaq:AGRX), a women's health specialty pharmaceutical company focused on the development and commercialization of new prescription contraceptive products, today reported financial results for the quarter ended March 31, 2015.
Almost Family, Inc. (Nasdaq:AFAM), a leading regional provider of home health nursing and personal care services, announced today that Steve Guenthner, President and Principal Financial Officer is scheduled to present at the Bank of America Merrill Lynch 2015 Health Care Conference in Las Vegas, Nevada.
Biocept, Inc. (Nasdaq:BIOC), a molecular diagnostics company commercializing and developing liquid biopsies to improve the diagnosis and treatment of cancer, today reported financial results for the three months ended March 31, 2015.
Capricor Therapeutics, Inc. (Nasdaq:CAPR), a biotechnology company focused on developing novel therapeutics for the treatment of cardiovascular diseases, today provided a business and financial update for the first quarter ended March 31, 2015.
Cara Therapeutics, Inc. (Nasdaq:CARA), a biotechnology company focused on developing and commercializing new chemical entities designed to alleviate pain and pruritus by selectively targeting kappa opioid receptors, today announced financial results for the first quarter ended March 31, 2015 and provided an update on its Phase 3 Program for I.V. CR845.
CareDx, Inc. (Nasdaq:CDNA), a molecular diagnostics company focused on the development and commercialization of clinically differentiated, high value, non-invasive surveillance solutions for transplant recipients, today reported financial results for the three months ended March 31, 2015.
EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic ultrasound, today announced financial results for the first quarter ended March 31, 2015 and provided an update on recent strategic developments.
Fibrocell Science, Inc., (Nasdaq:FCSC), an autologous cell and gene therapy company primarily focused on developing first-in-class treatments for rare and serious skin and connective tissue diseases with high unmet medical needs, today announced that the U.S. Food and Drug Administration (FDA) has granted rare pediatric disease designation for Fibrocell's lead orphan gene-therapy drug candidate, FCX-007, for the treatment of recessive dystrophic epidermolysis bullosa (RDEB).
Foamix Pharmaceuticals Ltd. (Nasdaq:FOMX), a clinical stage specialty pharmaceutical company focused on developing and commercializing proprietary topical foams to address unmet needs in dermatology, announces financial results for the three months ended March 31, 2015.
In RadNet, Inc.'s (Nasdaq:RDNT) financial results press release dated May 11, 2015, there was an incorrect webcast link in the Conference Call information for simultaneous and archived replay.
Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA), a biotechnology company specializing in the characterization and engineering of complex drugs, today announced that its presentation at the UBS 2015 Global Healthcare Conference will be webcast on Tuesday, May 19, 2015 at 4:30 p.m. ET.
OXiGENE, Inc. (Nasdaq:OXGN), a clinical-stage biopharmaceutical company developing novel therapeutics to treat cancer, today announced the appointment of a new President and Chief Executive Officer, Bill Schwieterman, M.D.
Quotient Limited (Nasdaq:QTNT), a commercial-stage diagnostics company, today announced that financial results for its fiscal fourth quarter and year ending March 31, 2015 will be released after market close on Monday, May 18, 2015.
Swisher Hygiene Inc. (Nasdaq:SWSH), a leading service provider of essential hygiene and sanitizing solutions, today announced that it has completed the sale of the assets of its Gulf Coast Laundry Services for $4.0 million in cash plus purchased accounts receivable.
Urologix, Inc. (OTCQB:ULGX), the leading provider of in-office procedures for the safe, durable and effective treatment of BPH, today announced an upcoming presentation at the American Urological Association (AUA) 2015 annual meeting to be held May 15-18, 2015 in New Orleans, LA.
Vital Therapies, Inc. (Nasdaq:VTL), a biotherapeutic company developing ELAD®, a cell-based therapy targeting the treatment of liver failure, today announced results for the first quarter ended March 31, 2015 and provided a corporate update.
Xenon Pharmaceuticals Inc. (Nasdaq:XENE), a clinical-stage biopharmaceutical company, today reported its financial results for the quarter ended March 31, 2015 and provided a corporate update.
Zafgen, Inc. (Nasdaq:ZFGN), a biopharmaceutical company dedicated to significantly improving the health and well-being of patients affected by obesity and complex metabolic disorders, today announced its first quarter 2015 financial results.