Wednesday, December 11, 2013
5:47 PMProthena +5.3% AH, inks collaboration deal with Roche for Parkinson's antibodies
- Prothena (PRTA) shares jump 5.3% AH after the company enters a worldwide collaboration deal with Roche to develop and commercialize antibodies targeting alpha-synuclein, including PRX002, Prothena's Parkinson's treatment (expected to enter Phase I trials in 2014).
- In the U.S., the companies will share all development and commercialization costs, as well as profits, on a 70%-30% basis in favor of Roche. Outside America, Roche will have sole development responsibility and pay Prothena "up to double-digit royalties."
- Under the agreement, Prothena will receive an upfront payment of $45M, with the company eligible for additional payments of up to $380M contingent on development/sales milestones and up to $175M in ex-U.S. commercial milestone payments.
5:38 PMGenVec +23.6% AH after RAC approves initiation of CGF166 phase I study
- GenVec (GNVC) shares spike 23.6% AH after the company discloses the National Institutes of Health's Recombinant DNA Advisory Committee unanimously approved the initiation of a Phase I study of CGF166, an adenoviral vector engineered to express the atonal gene in patients with severe hearing loss. (8-K)
- CGF166 uses GenVec's adenovectors tech and is being developed by the Novartis Institute for Biomedical Institute under a research collaboration and license agreement with GenVec.
- An investigational new drug application is expected to be filed in Jan.
4:58 PMathenahealth stumbles on weak 2014 outlook
- athenahealth (ATHN) reaffirms its FY13 outlook and provides guidance for FY14.
- FY13: Adjusted EPS of $1.05-1.15 on revenue of $580-615M.
- FY14: Adjusted EPS of $0.98-1.10 on revenue of $725-755M.
- Consensus for 2014 is $1.38/share on sales of $765.28M.
- CFO Tim Adams is "very excited about growth opportunities and [is] pleased to present an ambitious financial plan for fiscal year 2014." (PR)
- Investors don't seem so excited: ATHN -12% AH.
4:23 PMImmunoCellular cut in half as ICT-107 misses primary OS endpoint
- ImmunoCellular (IMUC) collapses 50% AH.
- The company is out with results from a Phase 2 study of ICT-107 in newly diagnosed glioblastoma multiforme.
- ICT-107 showed statistically significant PFS superiority over placebo. K-M curves (entire sample of 124 patients): Favors ICT-107; HR of 0.56; p=0.014; median PFS increase was two months. K-M curves (per-protocol population): Favors ICT-107; HR of 0.53; p=0.0074; median PFS increase was three months.
- OS K-M curves fail to hit statistical significance. OS was the primary endpoint. Summary (intent-to-treat): HR of 0.87; p=0.58. Summary (per-protocol): HR of 0.79; p=0.40.
- For more, see here.
2:47 PMDeutsche downplays alleged "price war" for Gilead, AbbVie HCV drugs
- "The biggest U.S. drug benefits manager plans to start a price war over a new generation of hepatitis C treatments that will cost $1,000 a pill, in a bid to drive down spending on the medicines," Bloomberg said Tuesday, tying comments made by Express Scripts (ESRX -0.5%) CMO Steven Miller to pricing for Gilead's (GILD -2.1%) sofosbuvir and upcoming HCV treatments from AbbVie (ABBV +1.2%).
- Deutsche's Robyn Karnauskas thinks the comments might have been taken out of context given that "the CMO did not mention GILD or any other company/drug."
- Other takeaways from Deutsche's conversation with ESRX: The company says it "spoke about various formulary changes and [while] HCV might be one of them, this is not something new [as it] works on formularies everyday."
- Also: ESRX says it does not "comment on drug/companies specifically. For Gilead drug, the internal committee still has to vote."
2:12 PMCelgene, Agios extend cancer collaboration
- Agios Pharmaceuticals (AGIO -4.4%) and Celgene (CELG -2.2%) extend the exclusivity period tied to a strategic cancer metabolism collaboration agreement (originally struck in 2010) by a year.
- Terms call for CELG to retain its exclusive option on any drug candidates that come out of the AGIO cancer metabolism pipeline until April of 2015.
- CELG is making an upfront payment of $20M to AGIO. (PR)
1:46 PMGW Pharmaceuticals gets patent for use of cannabinoids in glioma| 1 Comment
12:08 PMLimited impact for MCO names from budget deal: Deutsche
- "Any hopes of a roll-back of the 2% Medicare sequestration cuts were dashed as more details of the plan were revealed over the course of the evening," Deutsche's Scott Fidel notes, referencing the new U.S. budget agreement.
- "In fact," Fidel continues, "under the budget deal the 2% Medicare payment cuts will actually be extended by two years through 2023."
- Nevertheless, Deutsche doesn't think anyone was expecting much in the way of a roll-back anyway, and as such, the bank sees limited impact for MCO names.
- AET, CI, HNT, HUM, UNH, WLP
11:55 AMUBS out positive on new Cardinal, CVS JV
- Cardinal Health (CAH +0.6%) "expects the JV to be neutral to EPS in FY14 (ending in June), but should be accretive in FY15, w/ greater accretion in FY16," UBS notes, referring to the new generic sourcing entity the company has created with CVS Caremark.
- Analyst Steven Valiquette sees a $0.10-0.22 pro forma EPS opportunity by 2016.
- Price target raised to $77 from $70.
10:50 AMAegis reiterates bullish outlook for Auxilium
- Peyronie's is "tailor-made for [the company's] urology-focused specialty sales force," Aegis says, regarding the new PD indication for Auxilium Pharmaceuticals' (AUXL -1.3%) Xiaflex.
- Analyst Ram Selvaraju also notes that "the significantly higher number of vials of Xiaflex required to treat each Peyronie's disease patient is likely to translate into much greater revenue per patient in this indication vs. Dupuytren's contracture."
- Buy rating and $33 target maintained.
10:44 AMNanoString Tech rallies on expanded availability for breast cancer diagnostic test
- NanoString Technologies (NSTG +16.2%) is enjoying a strong session after announcing that the Prosigna Breast Cancer Prognostic Gene Signature Assay will be available nationwide in Q1 2014.
- LH and DGX have "chosen to add the Prosigna Assay to their comprehensive suites of breast cancer diagnostic tests," NSTG notes. (PR)
- Meanwhile, Baird is out with an upgrade to Outperform from Neutral. Price target is now $18 (from $12).
10:38 AMSummer Street defends Avanir after trial miss
- Summer Street is out positive on Avanir Pharmaceuticals (AVNR -19.9%) as the shares sell-off on a Phase 2 miss for AVP-923 in central neuropathic pain.
- "Once the trial enrollment was cut in half we did not think the trial was powered for statistical significance," analyst Carol Werther says, adding that "a neuropathic pain indication cannot be ruled out when positive Phase 3 results have been published in patients with type 2 diabetes."
- Werther is also upbeat on Nuedexta.
- Buy rating maintained.
- Price target cut to $10 from $17.
10:32 AMLabCorp sees its price targets cut after delivering weak guidance
- Analysts are beginning to weigh in on shares of Laboratory Corporation of America (LH -9.1%) after the company's guidance disappointed investors on Tuesday evening.
- Canaccord has cut the shares to Hold from Buy. Price target slashed to $91 from $115.
- Credit Suisse takes its price target to $92 from $104.
9:36 AMGlaxo to pump $330M into UK capacity
- GlaxoSmithKline (GSK +0.1%) is set to make a $330M investment in UK manufacturing, which should help with Relvar ramp.
- The move is being attributed to the country's "patent box" initiative, under which companies are, in Reuters' words, "offered a reduced rate of corporation tax on income derived from patents."
8:53 AMJefferies bullish on eHealth
- Jefferies starts eHealth (EHTH) at Buy.
- Analyst David Styblo thinks the company's "long-term growth trajectory is underappreciated."
- "Its leading online health insurance marketplace positions the company to generate 2013-17E revenue, EBITDA, and EPS CAGRs of 20%, 30%, and 40%," respectively, Styblo says.
- Price target is $56.
8:42 AMSpectrum Pharma outlines Marqibo, Folotyn studies
- Spectrum Pharmaceuticals (SPPI) is up 5% in premarket action.
- Out Wednesday morning are what the company calls "encouraging" data from Marqibo and Folotyn studies.
- Results from a Phase 2 study suggest Marqibo could have utility in the treatment of diffuse large B-cell lymphoma" (front-line). Summary: Marqibo substituted for Vincristin in R-CHOP; ORR, 95%; CRR, 90%; 10-year PFS, 64%; 10-year OS, 87%.
- As for Folotyn, data suggest the drug "may provide benefit to patients with early stage peripheral T-cell lymphoma." (PR)
8:23 AMCytRx reports positive top-line data from aldoxorubicin STS trial
- CytRx (CYTR) is out with top-line results from a Phase 2b study of aldoxorubicin in first-line metastatic, locally advanced or unresectable STSs.
- Summary (intent-to-treat analysis): Median PFS for aldoxorubicin, 8.4 months; median PFS for doxorubicin, 4.7 months.
- Summary (blinded central lab review): Median PFS for aldoxorubicin, 5.7 months; median PFS for doxorubicin, 2.8 months.
- OR rate: 25.4% for aldoxorubicin, 5.4% for doxorubicin.
- "These results are extraordinary for a single agent treating these chemotherapy-resistant tumors," the study's principal investigator says. (PR)
- CYTR +32% premarket.
8:11 AMEcho Therapeutics rises on Chinese licensing deal for Symphony System
- After rallying 8% Tuesday, shares of Echo Therapeutics (ECTE) are up some 26% in premarket action.
- The company has inked a licensing, development, and commercialization agreement with Medical Technologies Innovation Asia for the manufacture and distribution of the Symphony CGM System in China, Hong Kong, Macau, and Taiwan.
- Medical Technologies Innovation will take on the development, marketing, and manufacturing costs for the Chinese market, and will also be responsible for "obtaining regulatory approval for the product in the licensed territories."
- Medical Technologies Innovation is also entitled to $1.5M in development cost reimbursement, payable in ECTE stock.
- The companies will share any net sales of the system in the region. (PR)
7:59 AMLakewood outlines Opko short thesis
- On watch Wednesday morning are shares of Opko Health (OPK).
- Lakewood Capital has published its OPK short thesis on Seeking Alpha.
- Ultimately, Lakewood thinks "the shares are worth 75-100% less than where they are currently trading."
- "We believe it is unlikely shareholders will ever see a profit out of OPK," the firm says, adding that in their opinion, OPK "has become little more than a day trading vehicle."
- See also: OPK slides on Lakewood short position; StreetSweeper defends OPK
- Full SA article
- Full Lakewood report
7:32 AMSavient assets to be sold to Crealta Pharmaceuticals
- Bankrupt Savient Pharmaceuticals (SVNTQ) has agreed to sell substantially all of its assets to Crealta Pharmaceuticals for $120.4M.
- The figure is more than double the stalking horse bid of $55M made by Sloan Holdings.
- The assets include Krystexxa, Savient's uric acid-specific enzyme for treating chronic gout.
- The transaction is subject to approval by the bankruptcy court, which is due to hold a hearing about the agreement on Friday. (PR)
7:21 AMFDA grants priority review to Sanofi's Gaucher drug
- The FDA will carry out a priority review of Sanofi's (SNY) Eliglustat pill for Gaucher disease, a rare genetic disorder in which sufferers are deficient in an enzyme that breaks down a certain type of fat. That can lead to potentially fatal organ and bone problems.
- The FDA will now rule on whether to approve Eliglustat within six months instead of ten.
- The agency's move comes after the European Medicines Agency validated a marketing authorization application for Eliglustat in October.
- Analysts have forecast that Eliglustat, which would become the first oral treatment for Gaucher's disease, could generate annual sales of $517M by 2018. Other therapies include Sanofi's Cerezyme injection, Shire's (SHPG) Vpriv and Pfizer's (PFE) Elelyso.
- Sanofi shares are +1% in Paris.