Will AstraZeneca Get Bought After All?
Chris DeMuth Jr. • 20 Comments
Chris DeMuth Jr. • 20 Comments
The Preferred Way To Play The Allergan-Pfizer Break Up
Andrew Walker, CFA • 56 Comments
Andrew Walker, CFA • 56 Comments
Fri, May 13, 4:58 PM
- Pfizer (NYSE:PFE) has imposed controls on the distribution of its products to ensure that none are used in lethal injections, a step that closes off the last remaining open-market source of drugs used in executions, NY Times reports.
- More than 20 U.S. and European drug companies already have adopted such restrictions, but the decision from one of the world’s top drug manufacturers is considered a milestone.
- Now read Pfizer finally beats and raises cleanly enough to generate Alpha
Fri, May 13, 11:35 AM
- Prothena (PRTA +7.6%) initiated with Overweight rating and $60 (44% upside) price target by Barclays.
- Pfizer (PFE +0.5%) initiated with Hold rating and $38 (12% upside) price target by Berenberg.
- Amarin (AMRN +1.9%) initiated with Buy rating and $3.50 (111% upside) price target by Jefferies.
- Align Technology (ALGN +0.9%) initiated with Outperform rating and $84 (10% upside) price target by Credit Suisse.
- Presbia (LENS +2.9%) initiated with Buy rating and $14 (254% upside) price target by Rodman & Renshaw.
- LabStyle Innovations (OTCQB:DRIO +5.4%) initiated with Buy rating and $12 (121% upside) price target by Rodman & Renshaw.
- Juno Therapeutics (JUNO +1.5%) initiated with an Outperform rating and $55 (48% upside) price target by Cowen & Co.
- WebMD Health (WBMD +0.4%) upgraded to Buy from Neutral by SunTrust Robinson Humphrey. Price target increased to $75 (18% upside) from $57.
- Sanofi (SNY +0.3%) upgraded to Overweight from Equal Weight by Barclays. Price target maintained at €84 (20% upside).
- Depomed (DEPO +4.1%) upgraded to Buy from Neutral by Mizuho Securities. Price target raised to $19 (4% upside) from $18.
Fri, May 13, 8:18 AM
- Results from two large-scale Phase 3 trials showed the immunogenicity of Pfizer's (NYSE:PFE) TRUMENBA (Meningococcal Group B Vaccine) against invasive meningococcal B (MnB) strains that predominate in the U.S. and Europe. The data were presented at the 34th Annual Meeting of the European Society for Pediatric Infectious Diseases in Brighton, UK.
- One Phase 3 assessed TRUMENBA in 3,600 healthy individuals aged 10-18 in the U.S. and Europe. The primary endpoint was the percentage of subjects with an antibody response to four primary MnB strains. One month after doses two and three, the antibody responses were 64.0 - 99.1% and 87.1 - 99.5%, respectively.
- The second Phase 3 assessed TRUMENBA in 3,300 healthy people aged 18-25 in the U.S. and Europe. The primary endpoint was the same. One month after doses two and three, the antibody responses were 68.3 - 97.4% and 87.4 - 99.4%, respectively.
- The FDA approved TRUMENBA in October 2014 to prevent invasive disease caused by Neisseria meningitidis serogroup B in people 10-25 years old. In 2015, an advisory committee for the U.S. Centers for Disease Control recommended serogroup B meningococcal vaccination for certain people at least 10 years old who are at increased risk for meningococcal disease and recommended the administration of a MnB vaccine series to people 16-23 years old to provide short-term protection against most strains of MnB disease (preferred age range: 16-18).
Thu, May 12, 11:48 AM
- Kitov Pharmaceuticals (KTOV +10%) remains on track to file a New Drug Application (NDA) with the FDA seeking approval of lead product candidate KIT-302 by year end. The company's confidence in the timeline stems from the written minutes from its pre-NDA meeting with the agency.
- The FDA's feedback confirmed that six-month stability data will be acceptable and that an Advisory Committee review will not be required. Kitov also does not see a problem submitting the additional information requested, including market data, medical literature review of amlodipine and celecoxib in animals and the calculation of the primary efficacy endpoint using an alternative math technique, which KIT-302 met.
- Kitov intends to submit its marketing application under the abbreviated 505(b)(2) pathway which, if accepted, will enable approval in 2017.
- KIT-302 is a combination drug that treats osteoporosis-related pain (celecoxib, branded as Celebrex by Pfizer (PFE -0.3%)) and hypertension (amlodipine besylate, branded as Norvasc).
Thu, May 5, 11:38 AM| Thu, May 5, 11:38 AM | 11 Comments
Thu, May 5, 9:14 AM
- In a letter to Medivation's (NASDAQ:MDVN) board, Sanofi (NYSE:SNY) CEO Olivier Brandicourt reiterates his firm's strong desire to negotiate the terms of an acquisition, saying its $9.3B offer ($52.50 per share) represents a tidy 50% premium over what shares were trading three months before.
- He also says Sanofi has had extensive discussions with Medivation's top shareholders and they back the deal. Going a step further, he says Sanofi is prepared to go directly to shareholders if management does not proceed.
- A competing bid appears likely [Pfizer (NYSE:PFE), AstraZeneca (NYSE:AZN)] so whatever Medivation decides to do, Sanofi will probably have to up its offer.
- MDVN is up a fraction premarket while SNY is down 3%.
- Update: Medivation reiterates that Sanofi's bid is "substantially inadequate."
Wed, May 4, 4:31 PM
- The U.S. Court of Appeals for the Federal Circuit in Washington, DC will convene tomorrow in a rare session in which all 12 judges participate to hear arguments in a case that could have profound implications for the biopharmaceutical industry. The Court, which has national jurisdiction over all patent case appeals, will decide if an inventor's use of a third-party manufacturing service can invalidate the patentability of the invention, in this case the heart medication Angiomax (bivalirudin), an injectable anti-coagulant used during heart surgery.
- Inventor The Medicines Company (NASDAQ:MDCO) lost its patent infringement suit against generics firm Hospira (NYSE:PFE) when a three-judge panel ruled that two patents covering Angiomax, '727 and '343, were invalid due to a concept called "on-sale bar" which says that a product that is sold for at least a year before the patent application is submitted is not patentable. It was enacted to prevent inventors from extending their monopoly beyond the patent period. In this case, MDCO used a third-party manufacturer, Ben Venue Laboratories, to produce three batches of bivalirudin more than one year before submitting its patent applications because it was having difficulty making the drug in house.
- If the Court does not overturn the lower court's ruling, then it could have far-reaching implications for drugs/biologics makers since the use the manufacturing services firms is commonplace, even among large caps. Groups backing an overturn include the U.S. Department of Justice, the American Intellectual Property Law Association, the Intellectual Property Owners Association and the Pharmaceutical Research and Manufacturers of America.
Tue, May 3, 6:34 PM
- Medivation (NASDAQ:MDVN) +3.9% AH following a Reuters report that Pfizer (NYSE:PFE) has approached the company to express interest in an acquisition, raising the possibility of a bid rivaling Sanofi's (NYSE:SNY) $9.3B offer by Sanofi.
- MDVN has not yet decided whether it should engage with PFE in negotiations and is in discussions with its financial and legal advisers, according to the report.
- MDVN last week rejected SNY's $52.50/share takeover proposal, and PFE, Novartis (NYSE:NVS) and AstraZeneca (NYSE:AZN) have been speculated as potential suitors.
Tue, May 3, 7:43 AM
- Pfizer (NYSE:PFE) Q1 results ($M): Total Revenues: 13,005 (+19.7%); GEP: 4,773 (-4.8%); GIP: 3,640 (+18.4%): Vaccines: 1,570 (+18.2%); Consumer Healthcare: 822 (+1.7%); Oncology: 1,001 (+89.6%); Hospira: 1,199. Consensus: $12.02B.
- Net Income: 3,016 (+26.9%); Non-GAAP Net Income: 4,155 (+30.0%); EPS: 0.49 (+28.9%); Non-GAAP EPS: 0.67 (+31.4%). Consensus: $0.55.
- Key Product Sales: Prevnar Family: 1,509 (+15.5%); Lyrica: 1,229 (+3.5%); Enbrel (ex. U.S. & Canada): 733 (-3.4%); Ibrance: 429 (+999%); Lipitor: 411 (-6.8%); Viagra: 396 (0.0%); Sutent: 278 (+14.9%); Premarin Family: 256 (+10.3%); Norvasc: 236 (-6.3%); Cantix/Champix: 220 (+39.2%); Celebrex: 172 (-16.1%).
- 2016 Guidance: Revenues: $51B - 53B; EPS: $1.72 - 1.85; Non-GAAP EPS: $2.38 - 2.48.
- Q2 Consensus: EPS of $0.59 on revenues of $12.79B.
- Shares are up 2% premarket on increased volume.
Tue, May 3, 6:46 AM
Mon, May 2, 5:30 PM
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Fri, Apr. 29, 3:09 PM
- Also mentioned alongside AZN and PFE as weighing bids for Medivation (MDVN +2.3%) is Novartis (NYSE:NVS), according to the report.
- Earlier today, Medivation rejected Sanofi's (SNY -4.6%) $9.3B, or $52.50 per share offer, with one of Bloomberg's sources saying the company is looking for at least $65 per share. Sanofi has the capacity to go higher, say sources, but is naturally reluctant to overpay.
Thu, Apr. 28, 12:14 PM
Wed, Apr. 27, 9:51 AM
Fri, Apr. 22, 7:17 AM
- Sarepta Therapeutics (NASDAQ:SRPT) initiated with Neutral rating and $19 (73% upside) price target by Janney Capital.
- Alder BioPharma (NASDAQ:ALDR) initiated with Buy rating and $45 (61% upside) price target by Brean Capital.
- Pacira Pharmaceuticals (NASDAQ:PCRX) initiated with Buy rating and $79 (27% upside) price target by Mizuho Securities.
- McKesson initiated with Market Perform rating and $203 (14% upside) price target by Avondale Partners.
- Pfizer (NYSE:PFE) reinstated coverage with Neutral rating and $35 (6% upside) price target by Goldman Sachs.
- Allergan (NYSE:AGN) reinstated with Buy rating and $275 (21% upside) price target by Goldman Sachs. Downgraded to Neutral from Overweight by Piper Jaffray. Price target lowered to $238 (5% upside) from $311.
- Illumina (NASDAQ:ILMN) upgraded to 5.0 stars from 3.0 stars the Vetr community. Downgraded to Neutral by Bank of America with lowered price target of $180 (24% upside). Downgraded Hold from Buy by Cantor Fitzgerald and price target lowered to $165 (14% upside) from $225. Mizuho maintains Neutral rating and $150 (3% upside) price target.
- Sucampo Pharmaceuticals (NASDAQ:SCMP) upgraded to Buy from Neutral by Mizuho Securities. Price target maintained at $14 (19% upside).
- Medivation (NASDAQ:MDVN) upgraded to Buy from Hold by Canaccord Genuity. Price target raised to $70 (31% upside) from $45.
Wed, Apr. 20, 11:18 AM
- According to Leerink's Geoff Porges, drug makers appear to be taking little heed to politicians' outcries over high prices. In a research note, he says, "The price increases for established brands across our coverage have been substantial indeed. To the surprise of many investors, it now appears these price increases are likely to flow through to actual sales growth, with such growth more than offsetting any volume weakness in Q1 and resulting in significant positive revenue surprises for those companies when they report Q1 results."
- He cites Johnson & Johnson's (JNJ +0.8%) Q1 results released yesterday. Its total business was flat (+0.6%) but its pharmaceuticals unit was up 12.9%. His analysis showed as much as 90% of the list price increases are flowing through to reported sales, some as high as 100%.
- Over the past year, Amgen (AMGN +0.7%) increased its drug prices 8 - 28%, Gilead Sciences (GILD +0.9%) 10 - 18% for its HIV drugs and Biogen (BIIB -1.6%) 10 - 18%, according to Mr. Porges.
- Biogen reports tomorrow. Eli Lilly (LLY -0.3%), Baxalta (BXLT -1.4%), AbbVie (ABBV +0.9%), Celgene (CELG +0.4%), Bristol-Myers Sqibb (BMY +0.3%) and Shire (SHPG -1.6%) report next week. Pfizer (PFE +1%) and Merck (MRK -0.2%) report the week after. Amgen (AMGN +0.7%) is due to report shortly as is Gilead.
Pfizer, Inc. is a research-based, global biopharmaceutical company. The company's global portfolio includes medicines and vaccines, as well as many of the world's best-known consumer healthcare products. It collaborates with healthcare providers, governments and local communities to support and... More
Industry: Drug Manufacturers - Major
Country: United States
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