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BioCentury Extra
As published Friday, April 29, 2016 6:07 PM PST

  • Medivation rejects Sanofi bid

    To little surprise, Medivation Inc. (NASDAQ:MDVN) rejected an unsolicited bid from Sanofi (Euronext:SAN; NYSE:SNY) to acquire the company for $52.50 per share in cash, or about $9.3 billion. Sanofi made its offer public on Thursday (see BioCentury Extra, April 28).

    On Friday, Medivation said its board unanimously concluded the offer "substantially undervalues" the company. Medivation President and CEO David Hung said the "opportunistically-timed proposal" aims to "seize for Sanofi value that rightly belongs to our stockholders."

    Medivation cited several upcoming near-term milestones for the company that could add to its value, including an Oct. 22 PDUFA date for an sNDA that would add data to the label of prostate cancer drug Xtandi enzalutamide, and top-line data due in 1H17 from the Phase III EMBRACA trial of talazoparib (MDV3800).

    The sNDA would add Phase II data comparing Xtandi with Casodex bicalutamide. Medivation believes the update would "drive significantly greater adoption by urologists."

    EMBRACA is evaluating talazoparib to treat germline BRCA-mutant breast cancer. Medivation in-licensed the poly(ADP-ribose) polymerase (PARP) inhibitor last August from BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) (see BioCentury, Sept. 17, 2015).

    In response, Sanofi reiterated that it believes a takeout "represents a compelling strategic and financial opportunity" for Medivation's shareholders. The pharma said it "remains committed to the combination and looks forward to engaging directly with Medivation shareholders" concerning the proposal. Sanofi's offer price is a 40% premium to Medivation's close of $37.39 on March 30, before rumors surfaced the biotech hired JPMorgan to fend off unsolicited takeover offers.

    On an earnings call Friday, AstraZeneca plc (LSE:AZN; NYSE:AZN) CEO Pascal Soriot declined to comment on an analyst question about the pharma's "appetite for engaging in a very competitive bidding process" for Medivation. AstraZeneca has been rumored to have held internal talks about making a bid for Medivation.

    Sanofi slid EUR 4.08 to EUR 72.11 in Paris and $1.75 to $41.10 in New York on Friday. The pharma also reported 1Q16 financial results, including group sales of EUR 8.5 billion ($9.6 billion), up less than 1% in constant currency from 1Q15. The Street had expected sales of $9.9 billion. Sales of Sanofi's prostate cancer drug Jevtana cabazitaxel were EUR 90 million ($101.3 million) in the quarter, up 17% from 1Q15.

    Medivation gained $1.65 to $57.82 on Friday. The biotech is to report 1Q16 financial results May 5.

  • FDA approves Acadia's Nuplazid

    FDA approved Nuplazid pimavanserin from Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) to treat hallucinations and delusions associated with psychosis in Parkinson's disease patients. It is the first approved drug in the indication. Acadia plans to launch Nuplazid in June; the company declined to disclose its price.

    Last month, FDA's Psychopharmacologic Drugs Advisory Committee voted that Nuplazid's benefits outweighed its risks to treat Parkinson's disease psychosis (PDP). The small molecule serotonin (5-HT2A) receptor inverse agonist has breakthrough therapy designation to treat PDP (see BioCentury Extra, March 29).

    Acadia lost $0.10 to $32.30 on Friday. FDA announced the approval after market close. Acadia regained $0.10 to $32.40 in early after-hours trading.

  • AZ cutting costs, boosting oncology investment

    In its 1Q16 earnings report Friday, AstraZeneca plc (NYSE:AZN; LSE:AZN) said it would reduce core SG&A expenses to support continued investment in oncology. AZ estimated $1.1 billion in savings from unspecified cuts, primarily in commercial and manufacturing units, which would allow it to boost investment in oncology.

    The company reported EPS of $0.51 on $6.1 billion in total revenue, topping analysts' consensus of $0.49 per share on $6 billion in revenue.

    Separately, AZ terminated development of Tagrisso osimertinib in combination with durvalumab (MEDI4736) to treat non-small cell lung cancer (NSCLC), EVP and CMO Sean Bohen said on a conference call Friday. In October, the company halted enrollment in two studies, citing reports of interstitial lung disease-like events. Tagrisso is an oral irreversible inhibitor of EGFR-activating mutations and the T790M EGFR resistance mutation and the T790M EGFR resistance mutation approved to treat NSCLC. Durvalumab is a human IgG1 mAb targeting PD-L1 (see BioCentury Extra, Oct. 9, 2015).

    AZ shed $0.31 to $28.96 in New York on Friday and lost 31.5p to 3,928p in London.

  • New drugs backed by CHMP include Zavicefta, Zinbryta

    On Friday, EMA's CHMP recommended approval of several new drugs, including Zavicefta ceftazidime/avibactam (CAZ-104), Zinbryta daclizumab, Odefsey rilpivirine/emtricitabine/tenofovir alafenamide and Ongentys opicapone.

    The committee recommended Zavicefta from AstraZeneca plc (LSE:AZN; NYSE:AZN) to treat complicated urinary tract infection (cUTIs); complicated intra-abdominal infections (cIAIs); hospital-acquired pneumonia (HAP), including ventilator-associated pneumonia (VAP); and some Gram-negative bacterial infections for which there are limited treatment options. The fixed-dose combination of third-generation cephalosporin ceftazidime and broad-spectrum beta lactamase (LACTB) inhibitor avibactam is approved in the U.S. as Avycaz for cUTIs and cIAIs.

    CHMP recommended Zinbryta from Biogen Inc. (NASDAQ:BIIB) and partner AbbVie Inc. (NASDAQ:ABBV) to treat relapsing forms of multiple sclerosis. The companies expect a decision from FDA mid-year on a BLA for the humanized mAb against IL-2 receptor alpha chain (CD25). AbbVie has told investors it expects Zinbryta to be used more frequently in a second-line setting than first-line (see BioCentury, Oct. 26, 2015).

    The committee backed Odefsey from Gilead Sciences Inc. (NASDAQ:GILD) to treat HIV-1 infection in patients aged 12 and older with HIV-1 who lack known mutations associated with resistance to non-nucleoside reverse transcriptase inhibitors (NNRTIs). In March, FDA approved Odefsey, a single-tablet regimen that combines Gilead's Emtriva emtricitabine and tenofovir alafenamide with Edurant rilpivirine from Johnson & Johnson (NYSE:JNJ) (see BioCentury Extra, March 2).

    CHMP also recommended approval of Ongentys from Bial-Portela & Ca. S.A. (S. Mamede do Coronado, Portugal) as an adjunctive treatment to levodopa for Parkinson's disease (PD). According to EMA, the catechol-O-methyl-transferase (COMT) inhibitor increases levodopa plasma levels and decreases "off-time" and increases "on-time" without dyskinesia.

  • Gilead sinks after HCV sales miss estimates

    Gilead Sciences Inc. (NASDAQ:GILD) lost $8.79 to $88.21 on Friday after reporting earning that missed analyst estimates, in part due to lower than expected revenue from HCV drug Harvoni ledipasvir/sofosbuvir. The earnings report was released Thursday after market close (see BioCentury Extra, April 28).

  • ImmunoGen falls after modifying ovarian cancer trial

    ImmunoGen Inc. (NASDAQ:IMGN) sank $1.60 (19%) to $6.85 on Friday after disclosing it is modifying the FORWARD I trial of its lead internal program, mirvetuximab soravtansine (IMGN853). The company changed the study's eligibility criteria, primary endpoint and phase, and now hopes to seek full rather than accelerated approval in earlier lines of platinum-resistant ovarian cancer.

    ImmunoGen said FORWARD I, which is evaluating mirvetuximab soravtansine as a single agent to treat folate receptor 1 (FOLR1; FR-alpha)-positive platinum-resistant ovarian cancer, will now be a single-stage Phase III trial with progression-free survival (PFS) as the primary endpoint. It had intended FORWARD I to be a two-stage Phase II study with response rate as the primary endpoint to support accelerated approval.

    FORWARD I will still enroll ovarian cancer patients with medium or high FOLR1 expression, but ImmunoGen is now restricting the study to FOLR1-positive ovarian cancer patients who have been treated with up to three prior regimens, rather than those who had received three or four prior regimens.

    ImmunoGen said it is making the changes based on updated Phase I data showing confirmed responses were primarily in patients who had received three or fewer prior treatment regimens. That study includes patients who have received up to five prior lines of therapy. ImmunoGen intends to present those data at the American Society of Clinical Oncology (ASCO) meeting in June.

    On a conference call Friday, EVP and Chief Development Officer Charles Morris said the response rate in the Phase I study's overall population, regardless of lines of prior therapy, was under "the 30% threshold that we have always felt would be important for single-agent development." In January, ImmunoGen had reported a 35% response rate among 20 patients in the study.

    Mirvetuximab soravtansine is a FOLR1-targeting mAb linked to ImmunoGen's DM4 cytotoxic agent.

    ImmunoGen also reported fiscal 3Q16 earnings on Friday. For the quarter, ImmunoGen reported a loss of $0.37 per share, wider than the $0.31 consensus estimate. It cut full-year revenue guidance to $60-$70 million from $70-$80 million.

  • Former Kythera team raises $34M for Sienna

    Aesthetic dermatology play Sienna Biopharmaceuticals Inc. (Westlake Village, Calif.) raised $34 million in a series A round. The start-up's management team includes former executives from aesthetics company Kythera Biopharmaceuticals Inc., which Allergan plc (NYSE:AGN) acquired last year for about $2.1 billion.

    Arch Venture Partners led the round. Altitude Life Science Ventures, Partner Fund Management, and Venvest Capital also participated, as did individual investors.

    Sienna said its Silver Plasmonic Therapy (SPT), which uses plasmonic particles activated by laser light, is in clinical trials for acne and permanent removal of light pigmented hair. The company said current laser hair removal technologies only work on dark pigmented hair.

    Sienna's President and CEO is Frederick Beddingfield III, who was Kythera's CMO. Sienna Executive Chairman Keith Leonard was Kythera's co-founder, president and CEO.

    Arch, Altitude and Partner were all Kythera investors.

  • Theravance, Ignyta raise follow-ons

    Theravance Biopharma Inc. (NASDAQ:TBPH) and Ignyta Inc. (NASDAQ:RXDX) raised a combined $150 million in follow-ons.

    Theravance raised $100.1 million through the sale of 4.8 million shares at $21. The company proposed the offering after market close on Wednesday, when its share price was $23.57; it had hoped to sell 4.3 million shares. Leerink, Evercore ISI, Guggenheim and Baird are underwriters. Theravance and partner Mylan N.V. (NASDAQ:MYL) are conducting three Phase III studies of revefenacin (TD-4208), an inhaled long-acting muscarinic antagonist (LAMA), to treat chronic obstructive pulmonary disease (COPD). Theravance dipped $0.41 to $20.75 on Friday.

    Ignyta raised $50 million through the sale of 8 million shares at $6.25 in its offering, which is underwritten by JPMorgan, Piper Jaffray and Ladenburg Thalmann. The biotech proposed the offering Wednesday after market close, when its share price was $7.53. Ignyta's entrectinib (RXDX-101), which inhibits c-ros proto-oncogene 1 receptor tyrosine kinase (ROS1), anaplastic lymphoma kinase (ALK) and the tropomyosin receptor kinase (TRK) family, is in the Phase II STARTRK-2 "basket study." Ignyta gained $0.13 to $6.92 on Friday (see BioCentury, Nov. 9, 2015).

  • U.K. scientists oppose Brexit

    In an editorial in The Lancet Oncology, a group of U.K. cancer researchers urged the U.K. to remain in the EU to guarantee continued access to scientific resources. The U.K. will vote on a referendum to leave the EU on June 23.

    The authors said U.K. researchers would lose access to some sources of funding if the country left the EU. They said scientists have received about EUR 4 billion ($4.5 billion) in research funding from the EU's Seventh Framework Programme (FP7), and EUR 150 million ($168.8 million) from the European Research Council.

    The authors also emphasized the benefits of EU-wide collaboration in informing changes to clinical practice, and suggested withdrawal from the EU could hurt U.K. institutes' ability to recruit top EU scientists.

    The group included the University of Leeds' Peter Selby, Queen's University Belfast's Mark Lawler and Patrick Johnston, the European Cancer Organisation's Ian Banks, and the Francis Crick Institute's Paul Nurse, who was president of the Royal Society.

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