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There were not many developments in the pharma sector this week. Swiss pharma giant Roche RHHBY announced that it is buying the remaining stake in molecular information company, Foundation Medicine, Inc. FMI for $2.4 billion. Small drugmaker, PTC Therapeutics, Inc. PTCT unveiled promising early-stage data on its spinal muscular atrophy (SMA) candidate.
Recap of the Week’s Most Important Stories
Roche to Buy Remaining Stake in Foundation Medicine: Swiss pharma giant Roche said it will buy the remaining stake in molecular information company, Foundation Medicine for $137 per share, which adds up to a total transaction value of $2.4 billion. The price of $137 marks a premium of 29% on the closing price of Foundation Medicine on Jun 18 and values the Cambridge, MA-based company at $5.3 billion. The deal aims to strengthen Roche’s development efforts of personalized therapies to treat cancer by leveraging Foundation Medicine’s high quality comprehensive genomic profiling (CGP) testing and innovative data services. The deal is expected to close in the second half of the year. Roche initially had bought roughly 57% stake in Foundation Medicine in 2015 for around $1 billion. (Read More: Roche to Buy Rest of Foundation Medicine for $2.4 billion)
PTC Therapeutics Unveils Promising Early-Stage Data on SMA drug: PTC Therapeutics presented encouraging preliminary data from an early-stage study evaluating its gene therapy candidate, risdiplam in babies with type 1 spinal muscular atrophy (“SMA”). The early-stage data demonstrated improved muscle performance in nearly 90% of babies treated with risdiplam. Shares of PTC Therapeutics rose almost 28% in response to the news.
However, shares of PTC Therapeutics declined sharply on, the day following the announcement. This was because rival company, Sarepta Therapeutics announced better-than-expected results from an early-stage study, evaluating its gene therapy as a treatment for patients with Duchenne muscular dystrophy (DMD). PTC Therapeutics also markets therapies to treat DMD.
FDA Accepts Bristol-Myers sBLA for Opdivo/Yervoy Combo in Lung Cancer: Bristol Myers’ BMY supplemental biologics license application (sBLA) for label expansion of its PD-L1 inhibitor Opdivo (nivolumab) in combination with low-dose Yervoy in first-line lung cancer was accepted by the FDA. Bristol Myers is looking to get this combination of two immunotherapy drugs approved for the treatment of non-small cell lung cancer in patients with tumor mutational burden ≥10 mutations per megabase. The FDA is expected to give its decision on Feb 20 next year.
Shire’s HAE Drug Gets FDA Nod for Pediatric Population: Shire gained FDA approval for label expansion of its hereditary angioedema (HAE) drug Cinryze to include use in pediatric patients 6 years and older. Cinryze was approved in the United States in October 2008 for routine prophylaxis, against attacks in adolescents and adults living with HAE, a rare genetic disorder that causes painful swelling to various parts of the body. The approval for the pediatric population should drive sales of the drug higher in future quarters.
Novo Nordisk Signs Deal with Kallyope; Presents Positive Diabetes Studies Results: Denmark based pharma giant Novo Nordisk NVO entered into a collaboration with New York based biotech Kallyope Inc. to discover peptide therapeutics for obesity and diabetes. Per the deal, Kallyope will receive an upfront payment and potential research, development and sales milestones depending on the terms of the deal. Novo Nordisk also has an option agreement to license exclusive worldwide rights to develop and commercialize up to six products discovered as part of the collaboration. In case, Novo Nordisk exercises the option, Kallyope will be entitled to receive a license fee.
Novo Nordisk also presented headline results from two phase III studies on the oral formulation of its type II diabetes medicine, semaglutide. While the first study (PIONEER 4) compared oral semaglutide to Novo Nordisk’s other diabetes medicine Victoza, the other study (PIONEER 7) compared oral semaglutide to Merck’s (MRK) Januvia (sitagliptin). Both the studies showed that oral semaglutide led to statistically significant reductions in HbA1c and weight compared to Victoza and Januvia, respectively. Semaglutide is presently sold as Ozempic, a weekly injection in several countries.
The NYSE ARCA Pharmaceutical Index declined 1% in the last five trading sessions.
Large Cap Pharmaceuticals Industry 5YR % Return
Large Cap Pharmaceuticals Industry 5YR % Return
Here is how the seven major stocks performed in the last five trading sessions:
All the stocks recorded a decline last week, except Pfizer PFE and Bristol-Myers, which were flat. Glaxo declined the most (1.6%)
In the past six months, Glaxo GSK has been the biggest gainer (17.5%) while J&J declined the most (13.4%).
(See the last pharma stock roundup here: Pharma Stock Roundup: LLY/AZN Alzheimer's Drug Fails, MRK's Keytruda Wins Approvals)
What's Next in the Pharma World?
Watch out for FDA decisions on several pipeline drugs and line extensions of marketed products this month.
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Foundation Medicine, Inc. (FMI) : Free Stock Analysis Report
Roche Holding AG (RHHBY) : Free Stock Analysis Report
Bristol-Myers Squibb Company (BMY) : Free Stock Analysis Report
Pfizer Inc. (PFE) : Free Stock Analysis Report
Novo Nordisk A/S (NVO) : Free Stock Analysis Report
GlaxoSmithKline plc (GSK) : Free Stock Analysis Report
PTC Therapeutics, Inc. (PTCT) : Free Stock Analysis Report
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