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29 июня 2015, 22:14

Premarket Biotech Digest: Trouble For Stryker Sub's Ex-CEO; Zoetis Merger Rumors


Summary

  • In today's news, Otismed's ex-CEO sentenced to 24-month prison term, Zoetis falls post merger rumors, and Veracyte is higher on the Aetna agreement.
  • Gilead still looks like one of the best biotech stocks; Google enters biotech field with the Genomic Analysis Toolkit on its Cloud Platform.
  • Isis and Pfizer have received new ODDs.

The iShares Nasdaq Biotechnology Index ETF (NASDAQ:IBB) closed 0.81% lower on Friday. The index, though, is headed for monthly gains in June. IBB is also up for the second quarter.

Dr. De's Opening Thoughts

Today, I was thinking about ethnic methods of treatment, like acupuncture, ayurveda, homeopathy etc. As a physician, I am supposed to be skeptical of these things, yet quite often I have been pleasantly surprised by the efficacy and especially safety of some of the medicines in ayurveda or homeopathy for simple diseases like irritable bowel or a touch of flu. I don't think ayurveda has any publicly traded company, nor that Boiron or Hahnemann, major homeopathy labs, have a public market presence in the US. If there were a holding company trading in the major US markets and composed of some smaller ethnic medicine companies, I would be very interested as an investor. A couple of companies have some interest in these areas - Nutra Pharma (OTCPK:NPHC) has Cobroxin, a cobra venom painkiller, and TheraBiogen (OTCPK:TRAB) has the Theramax group of products - but none of these are major names in the homeopathy sector.

Sector News

FDA Receives Complaint About Bayer's Sterilization Implant Product: The complaints received center on adverse reactions, including cases of deaths, from women who had a sterilization implant called Essure. Bayer AG (OTCPK:BAYRY) acquired the product when it purchased a majority stake in Conceptus Inc.

Zoetis Plunges A Day After Merger Rumors: Animal health company Zoetis Inc. (NYSE:ZTS) saw a sharp decline in its shares on Friday, a day after the stock had rallied on a Wall Street Journal report that Valeant Pharmaceuticals International (NYSE:VRX) was planning to acquire the company. On Friday, Zoetis shares fell more than 12%, giving up all of their gains from the previous trading session.

Veracyte Signs Agreement with Aetna: Veracyte (NASDAQ:VCYT) has entered into an agreement with Aetna (NYSE:AET). Under the terms of the agreement, VCYT has now become part of AET's laboratory network, effective July 1, 2015. VCYT's Afirma Thyroid FNA analysis is a proprietary Gene Expression Classifier (GEC) test, which is used as part of thyroid cancer diagnosis. On Friday, Veracyte shares finished more than 6% higher.

Calmare Therapeutics Reports Extension of GSA Contract: Calmare Therapeutics (OTCPK:CTTC) announced a preliminary three-month extension of its General Services Administration (GSA) military contract. The contract was first awarded to CTTC in 2010, and is designed to continue the streamlined procurement process for U.S. military personnel and their families and institutional customers across the global who acquire Calmare Pain Therapy Devices and its consumables.

Google Announces Partnership With Broad Institute: Technology giant Google (NASDAQ:GOOG) has announced a partnership with Broad Institute of MIT and Harvard to launch the institute's Genomic Analysis Toolkit (GATK) on its Cloud Platform. The company will make GATK available as a service.

Drug Approvals

As of the last reporting date (June 25, 2015), there was one tentative approval for CABAZITAXEL from Accord Healthcare, which is a private company - for "intravenous use only in combination with prednisone for treatment of patients with hormone-refractory metastatic prostate cancer previously treated with a docetaxel-containing treatment regimen."

Galena Biopharma's (NASDAQ:GALE) ZUPLENZ received approval for a new dosage form. ZUPLENZ was FDA-approved back in 2010 for nausea post chemotherapy. Eisai had 2 labeling revisions for its drug Banzel.

Isis Pharmaceuticals (NASDAQ:ISIS) received an Orphan Drug Designation (ODD) for its "volanesorsen sodium, apolipotrotein C-III antisense oligonucleotide" for treatment of familial chylomicronemia syndrome. Pfizer (NYSE:PFE) received an ODD for its compound for the "treatment of anaplastic lymphoma kinase (ALK)-positive or ROS1-positive non-small cell lung cancer."

In the EU, a number of new medicines were approved. Kanuma from Synageva BioPharma Corp. (NASDAQ:GEVA), intended for the treatment of lysosomal acid lipase (LAL) deficiency, was approved and given marketing authorization. According to the EMA website, "the benefits with Kanuma are its ability to replace the activity of the missing enzyme resulting in reduced liver fat content and reduced levels of blood transaminases, low-density lipoprotein (LDL) cholesterol, non-high-density lipoprotein (HDL) and triglycerides. In addition, there was a significant benefit in terms of survival (67%) in infants with Wolman disease beyond 12 months." Hospira (NYSE:HSP) received approval for its generic breast cancer, non-small lung cancer, prostate cancer, gastric adenocarcinoma, and head and neck cancer drug Docetaxel. Novartis (NYSE:NVS) received approval for Odomzo, intended for the treatment of adults with locally advanced basal cell carcinoma. The company also received approval for Farydak, intended for the treatment of relapsed and/or refractory multiple myeloma, which had received ODD in 2012.

Regulatory

Yesterday, Charlie Chi, the former CEO of Otismed, was sentenced to 24 months in prison for shipping adulterated knee replacement cutting guides. Last year, Otismed was forced to pay an $80 million fine as liability. Without receiving an FDA approval, but falsely representing as such, Otismed sold more than 18,000 OtisKnee devices used for knee replacement surgery, generating revenue of approximately $27.1 million between May 2006 and September 2009.

Otismed is a subsidiary of Stryker (NYSE:SYK). Stryker had acquired Otismed for $103 million back in November 2009, just after much of the criminal activities in question had already happened.

Trials and results

No trial results were posted as of the last reporting date.

Earnings

ERBA Diagnostics Shares Drop After Missing Estimates: ERBA Diagnostics (NYSEMKT:ERB) shares edged lower on Friday after the company missed Q1 earnings estimates. The company reported revenue of $4.9 million and a net loss of $1 million for the first quarter. Mohan Gopalkrishnan, CEO of ERBA Diagnostics, said that the first quarter for the company was a period of re-organization, as it focused on talent search for key management positions to better align with its longer-term growth strategy.

Secondary Offerings

Veracyte Files S3: On June 24th, Veracyte filed an S3 with the Securities and Exchange Commission (SEC). The registration will enable the company to issue various types of securities, including common stock, preferred stock, warrants, units and/or rights to acquire any of these securities from time to time. The aggregate amount of offering is $125 million.

IPOs

Catabasis Pharmaceuticals Completes IPO: Catabasis Pharmaceuticals (Pending:CATB) has completed its IPO. Based in Cambridge, Massachusetts, CATB focuses on the discovery, development and commercialization of therapeutics based on a technology platform called SMART, which refers to safely metabolized and rationally targeted linker. The offering of 5,000,000 shares was priced at $12 per share. On Friday, CATB shares closed 3.62% higher at $13.47.

Insider Transactions

FibroGen CEO Sells: FibroGen (NASDAQ:FGEN) CEO Thomas B. Neff sold 27,000 shares in two separate transactions. Neff sold 13,500 shares at $23.62 and another 13,500 shares at $23.52.

Big Movers

Among the major gainers in the biotech sector on Friday was Opko Health (NYSE:OPK). Shares of the Miami, Florida-based company closed 3.69% higher at $16 on Friday. On the Nasdaq, the big biotech gainer was Seres Therapeutics (Pending:MCRB), which closed 185.66% higher. Seres, of course, completed its IPO, and the huge gains indicate the demand for MCRB shares. Cellular Biomedicine Group (OTCQB:CBMG) shares surged 13.34% to finish at $38.99.

Major losers on Friday included Zoetis, which closed 12.08% lower. Glaukos (Pending:GKOS), which was another biotech IPO from last week, closed 10.31% lower. On the Nasdaq, the big loser was Celladon Corp. (NASDAQ:CLDN), which fell 38.64% after announcing that it plans to suspend its development of Mydicar, as well as its other preclinical programs.

Focus Ticker

The focus ticker for today is Gilead Sciences (NASDAQ:GILD). The past week saw a number of publications on Seeking Alpha with regard to Gilead. Most, not surprisingly, were bullish on GILD. Although the shares are already up more than 25% so far this year, Gilead bulls, which include this author, expect further upside. The gains going forward will continue to be driven by the strong performance of Gilead's hep C franchise and the lack of real competition except AbbVie's (NYSE:ABBV) Viekira Pak and a possible Merck (NYSE:MRK) offering 2 years down the line. As I noted in an article last week, Gilead is set for another strong quarter and beat consensus forecast for revenue.

Fresh prescription data for Sovaldi/Harvoni is now available. According to RBC analysts Michael Yee and John Chung, written prescriptions for Harvoni dropped 5% for the week ended June 19. My last article had data available until June 12. Harvoni prescriptions totaled 8,708, while Sovaldi/Harvoni prescriptions totaled 10,376. This takes total prescriptions for Harvoni/Sovaldi for the month of June to 33,700. At this rate, prescriptions for the month of June should total around 145,000, which is in line with the estimates I had provided in the previous article.

Source: http://seekingalpha.com/article/3289685-premarket-biotech-digest-trouble-for-stryker-subs-ex-ceo-zoetis-merger-rumors?source=feed_articles_sectors_technology