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Pharma Friday 5/25-5/31

|Includes: ALT, AMGN, AstraZeneca Group plc (AZN), ENDP, EPZM, EW, GSK, OVTI, QGEN, SIGA, SQNM, TFX

M&A Etc.

  1. AZN is paying $12.70 a share for Omthera, or $323 million, along with up to $120 million in contingent value rights, based on the success of Omthera's omega-3 drug Epanova. Will compete with, GlaxoSmithKline (NYSE:GSK) Lovaza -- $559mm, and Amarin's (NASDAQ:AMRN) Vascepa
  2. PharmAthene (PIP) sued Siga Technologies (NASDAQ:SIGA) because it violated promises to negotiate in good faith over a license for ST-246, an antiviral drug for use in case of a biological attack. In its lawsuit, PharmAthene argued it had a claim to ST-246's profits because it helped fund the drug's development and Siga reneged on promises to grant a licensing agreement. This dispute stems from the fact that Siga won a five-year U.S. government contract for 2 million doses of ST-246 in a deal that could be worth as much as $2.8 billion
  3. GlaxoSmithKline Plc (GSK) acquired Okairos AG, a development stage Swiss vaccine company, for 250 million euros ($324 million). Okairos uses viruses to deliver genetic material into cells, stimulating the immune system
  4. Amgen (NASDAQ:AMGN) has entered into a long-term collaboration with Astellas Pharma (OTCPK:ALPMF) and will form a joint venture with the Japanese drugmaker to provide new medicines in Japan. Amgen will initially own 51 percent of the joint venture and it will become fully owned by the U.S. biotech as soon as 2020, the companies added. The companies will develop 5 Drugs together -- three late stage and two early stage. Late Stage drugs include -- cholesterol medicines called PCS-K9 inhibitors, osteoporosis treatment romosozumab, and gastric cancer medicine rilotumumab. Early stage drugs include -- AMG-337 for gastric cancer, blinatumomab, which is being tested against acute lymphoblastic leukemia and non-Hodgkin's lymphoma. Of note, Gastric Cancer is a particular problem in China. This comes on the heels of Amgen's and Zhejiang Beta Pharma JV to commercialize Amgen's Vectibix for metastatic colorectal cancer, in the Chinese market.
  5. Ophthotech has raised $175 million from Novo A/S (NYSE:NVO) to cover a pivotal late-stage study of its lead drug for wet age-related macular degeneration (NASDAQ:AMD), Fovista. $125mm will get NVO royalties in the drug, and $50mm will come in the form of series C financing. In a Phase IIb study with 449 patients, half of the patients recieved Lucentis & Fovista, and half only received Lucentis. Those receiving the combination of drugs had a 60% better letter recognition than those only receiving Lucentis.
  6. GE Healthcare ($GE) snatched up Unisyn Medical's ultrasound repair segment. The company's flagship product, FirstCall, can diagnose, repair and test ultrasound probes
  7. Sequenom ($SQNM) inked a deal to licence its technology to France's Laboratoire Cerba to expand the reach of the company's MaterniT21 Plus test, designed to noninvasively detect chromosomal abnormalities. The licence applies to France, Belgium, Luxembourg and 9 other countries in the Middle East and Africa
  8. Epizyme (NASDAQ:EPZM) -- took in ~$90mm in proceeds from an IPO on Friday. Epizyme uses epigenetics-a field of biology based on the idea of turning genes on and off without altering the underlying DNA-to create cancer drugs for small patient groups. As its name suggests, Epizyme harnesses epigenetics to target enzymes with its drugs. Still early stage, but already have partnerships with Roche and Merck for Companion diagnostic, and Celgene and Eisai for the international rights for two of its development drugs
  9. Qiagen (NASDAQ:QGEN) licenced two biomarkers recently. First, from Columbia University for FGFR-TACC fusion genes, whose expression marks glioblastoma, the most common and aggressive form of brain tumor. Second, from BC Cancer Agency for Y641 mutation of the EZH2 gene, a lymphoma-related flaw. Companion diagnostics are a key growth driver for Qiagen, CEO Peter Schatz said, and the company's personalized medicine business has swelled to about $100 million a year thanks to aggressive biomarker licensing and test development.

Regulatory News

  1. GSK gained approval for Tafinlar and Mekinist -- a pair of melanoma drugs. Tafinlar is a BRAF inhibitor for the V600E gene mutation, and will cost $7,600 for a 30-day supply. Mekinist is a MEK inhibitor for the V600E and V600K gene mutation, and will cost $8,700 for a 30-day supply. GSK also received approval for a companion diagnostic test to see if the patient has that mutation. Analysts estimate that each could generate $350 million in revenue. 76,690 Americans will be diagnosed with melanoma this year, with roughly 9,480 dying from the disease
  2. Teleflex (NYSE:TFX) received a CE mark for its GPSCath device, designed to prop open vessels and reduce procedure times for vascular interventions
  3. Edwards Lifesciences ($EW) received a warning letter from the FDA over problems at the company's Utah facility Cardiac Surgery Systems business, which manufactures cannulae, cardioplegia catheters. The good news is that the warning letter and its attendant restrictions have no effect on Sapien, Edwards' banner transcatheter heart valve
  4. Endo Health's (NASDAQ:ENDP) testosterone drug got a CRL, citing safety concerns. The FDA advised that the company add a medication guide and other elements to cut the risk of severe adverse reactions to the injected therapy, according to the company's release. Yet the company saw no mention of additional clinical study requirements, and Endo's chief scientist Ivan Gergel said the company plans to respond to the agency's requests by the end of the third quarter

Earnings News

  1. Omnivision (NASDAQ:OVTI) reported revenue of $336.2mm, an $18mm beat , and EPS of 17 cents, a 4 cents miss