News Column

FDA Issued Form 483 with 10 Inspectional Observations for Impax Taiwan Plant; Pfenex Announces Closing of Initial Public Offering

July 29, 2014



Below is a look at some of the headlines for companies that made news in the healthcare sector on July 29, 2014.

{nfg}Impax Laboratories, Inc. (NASDAQ: IPXL)
announced the U.S. Food FDA performed a general GMP inspection and a Pre-Approval Inspection (PAI) for RYTARYTM at the Company's Taiwan manufacturing facility from July 21 to July 26, 2014. At the conclusion of the inspection, the FDA issued a Form 483 with ten inspectional observations. The Taiwan facility was approved for product manufacturing by the FDA in September 2009 and by Taiwan FDA in July 2010. The facility currently manufactures 12 products for distribution in the United States.



The FDA did not provide any status or classification to these observations and, as is normal practice, will wait until they have received and reviewed the Company's response to provide this information. The Company has also not been informed by the FDA of the impact this Form 483 may have on RYTARY's October 9, 2014 review date under the Prescription Drug User Fee Act (PDUFA).



"We are already working diligently to address the observations raised by the FDA and will respond to these observations within the required 15 business day period from the receipt of the Form 483," said Fred Wilkinson, president and chief executive officer of Impax Laboratories. "We remain committed to our overarching goal of implementing a world class continuous quality improvement program and maintaining the highest quality standards across our facilities."



The Company has provided a redacted version of the Form 483 as an exhibit in a Current Report on Form 8-K filed with the SEC concurrently with the issuance of this press release.







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Pfenex Inc. (NYSE MKT: PFNX)
announced it has closed its previously announced initial public offering of 8,333,333 shares of its common stock at a price to the public of $6.00 per share. All of the common stock was offered by Pfenex. In addition, Pfenex has granted the underwriters a 30-day option to purchase up to 1,250,000 additional shares of common stock at the initial public offering price. The shares of common stock are traded on the NYSE MKT under the symbol "PFNX."



William Blair & Company, L.L.C. and JMP Securities LLC acted as joint book-running managers for the offering and Mizuho Securities USA Inc. acted as co-manager.



A registration statement relating to these securities was filed with, and declared effective by, the Securities and Exchange Commission on July 23, 2014. A copy of the final prospectus relating to the offering may be obtained from: William Blair & Company, L.L.C., Attention: Prospectus Department, 222 West Adams Street, Chicago, IL 60606, or by calling (800) 621-0687 or by emailing a request to prospectus@williamblair.com; or from JMP Securities LLC, Attention: Prospectus Department, 600 Montgomery Street, 10th Floor, San Francisco, CA 94111, or by calling (415) 835-8985.



This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.







Also Tuesday:





Advaxis, Inc. (Nasdaq:ADXS)
, a clinical-stage biotechnology company developing cancer immunotherapies, and the University of Pennsylvania signed an amendment to restructure their 2002 Exclusive License, which relates to Advaxis's proprietary Listeria monocytogenes Lm-LLO cancer immunotherapy technology.



Bacterin International Holdings, Inc. (NYSE MKT:BONE)
, a leader in the development of revolutionary bone graft material and coatings for medical applications, today announced that it will release its financial results for the period ended June 30, 2014, on August 12, 2014 at the close of the financial markets.



CAS Medical Systems, Inc. (Nasdaq:CASM)
, a leader in medical devices for non-invasive patient monitoring, today announced it will report financial results for the second quarter of 2014 on Wednesday, August 6, 2014, prior to the market's opening.



ContraFect Corporation (Nasdaq:CFRXU),
a biotechnology company focused on protein and antibody therapeutic products for life-threatening infectious diseases, will visit the NASDAQ MarketSite in Times Square in celebration of its initial public offering (IPO) which occurred on July 29, 2014.



Endocyte, Inc. (Nasdaq:ECYT)
, a leader in developing targeted small molecule drug conjugates (SMDCs) and companion imaging agents for personalized therapy, today announced financial results for the second quarter ending June 30, 2014, and provided a clinical update.



Fate Therapeutics, Inc. (Nasdaq:FATE)
, a biopharmaceutical company engaged in the discovery and development of adult stem cell modulators to treat orphan diseases, announced today that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug Application (IND) for the clinical development of PROHEMA® in pediatric patients undergoing hematopoietic stem cell (HSC) transplantation for the treatment of inherited metabolic disorders (IMDs).



Five Prime Therapeutics, Inc. (Nasdaq:FPRX)
, a clinical-stage biotechnology company focused on discovering and developing novel protein therapeutics for cancer and inflammatory diseases, will report its second quarter 2014 financial results on Tuesday, August 5, 2014, after the U.S. financial markets close.



Galena Biopharma, Inc. (Nasdaq:GALE)
, a biopharmaceutical company developing and commercializing innovative, targeted oncology treatments that address major unmet medical needs to advance cancer care, today announced that the Company will report its second quarter financial results on Monday, August 11, 2014 after the close of the financial markets.



Immune Design (Nasdaq:IMDZ)
announced today the closing of its initial public offering of 5,000,000 shares, at a public offering price of $12.00 per share, resulting in aggregate gross proceeds of $60.0 million, before underwriting discounts, commissions and expenses.



Intersect ENT, Inc. (Nasdaq:XENT)
, a commercial drug-device company committed to improving the quality of life for patients with ear, nose and throat conditions, today announced the closing of its initial public offering of 5,750,000 shares of its common stock at a public offering price of $11.00 per share, including 750,000 shares sold pursuant to the underwriters' option to purchase additional shares.



Inogen, Inc. (Nasdaq:INGN)
, a medical technology company offering innovative respiratory products for use in the homecare setting, announced today that it will release its financial results for the second quarter of 2014 after the close of trading on Tuesday, August 12, 2014.



Insulet Corporation (Nasdaq:PODD)
, the leader in tubeless insulin pump technology with its OmniPod® Insulin Management System, will visit the NASDAQ MarketSite in Times Square.



LeMaitre Vascular, Inc. (Nasdaq:LMAT)
today reported Q2 2014 results, provided guidance and announced a $0.035/share dividend.



MacroGenics, Inc. (Nasdaq:MGNX)
today announced that on Tuesday, August 5, 2014, the Company will release its financial results for the quarter ended June 30, 2014.



MELA Sciences, Inc. (Nasdaq:MELA),
developer of the MelaFind® system, an optical diagnostic device approved for use in the U.S. and the European Union to assist dermatologists in melanoma diagnosis, today announced that it has received a letter from The NASDAQ Stock Market advising that the Company has regained compliance with NASDAQ's minimum bid price listing requirement.



Merit Medical Systems, Inc. (Nasdaq:MMSI)
, a leading manufacturer and marketer of proprietary disposable medical devices used in interventional and diagnostic procedures, particularly in cardiology, radiology and endoscopy, today announced record revenues of $128.9 million for the quarter ended June 30, 2014, an increase of 17% over revenues of $109.9 million for the quarter ended June 30, 2013.



MTBC (Nasdaq:MTBC)
, a leading provider of proprietary, web-based electronic health records, practice management and mHealth solutions, today announced the closing of its previously announced initial public offering of 4,080,000 shares of its common stock at a price to the public of $5.00 per share.



Receptos, Inc. (Nasdaq:RCPT),
a biopharmaceutical company developing therapeutic candidates for the treatment of immune and metabolic diseases, today announced the appointment of Mary Szela and Richard Heyman to the board of directors of Receptos. Ms. Szela and Dr. Heyman will both serve as Class II directors with terms of office expiring and to be renewed at the 2015 annual meeting of stockholders.



Revance Therapeutics, Inc. (Nasdaq:RVNC)
, a biopharmaceutical company developing botulinum toxin products for use in aesthetic and therapeutic indications, announced today that the Company will release second quarter 2014 financial results on Tuesday, August 12, 2014 after the close of market.



SANUWAVE Health, Inc. (OTCQB:SNWV)
today announced that the Company will release financial results for the second quarter ended June 30, 2014 after the markets close on August 6, 2014.



Trinity Biotech plc (Nasdaq:TRIB)
, a leading developer and manufacturer of diagnostic products for the point-of-care and clinical laboratory markets, today announced results for the quarter ended June 30, 2014.


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Source: BioMed Reports


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