CHICAGO and new york, Aug. 17, 2016 (GLOBE NEWSWIRE) -- The female health company (FHC) and Aspen Park prescribed drugs, Inc. (APP) these days introduced that the U.S. food and Drug Administration (FDA) has agreed to an expedited regulatory pathway for APP's BPH drug Tamsulosin DRS (Delayed unlock Sachet). As previously announced FHC and APP have entered into a definitive merger settlement. a different meeting of FHC shareholders is scheduled for September 20, 2016 to approve matters relating to the proposed merger.
"FDA's resolution to allow us to utilize its 505(b)(2) regulatory pathway is a major milestone for the accelerated construction of our BPH product," noted Mitchell Steiner, MD, CEO and President of APP and the mixed company, Veru Healthcare, after completion of the proposed merger. "Our product is a novel powder which makes use of a proprietary prolonged unencumber method of the present lively ingredient in Flomax®. Many guys have issue swallowing tablets or capsules, which represents an unmet medical need. We believe the unconventional Tamsulosin DRS system can be a favored dosage kind for these sufferers. The U.S. market for Flomax® and its popular equivalents which are at the moment simplest available in tablet or tablet kind is a couple of $3.5 billion market. The 505(b)(2) pathway makes it possible for us to reference previous findings of defense and efficacy for an already authorized product (Flomax®), which extensively reduces our time and price to further increase the p roduct."
"extra chiefly, FDA additionally agreed with our plans to behavior a single bioequivalence examine to assist the filing of a NDA. We intend to provoke a three week bioequivalence look at in the fourth quarter of this yr and publish a NDA in 2017. apart from Tamsulosin DRS, APP has a deep portfolio of excessive profile drug product candidates in late and early levels of building, focused in the areas of oncology and guys's and women's fitness."
"contemporary announcement gives mighty further momentum for the merger of our two agencies," spoke of O.B. Parrish, Chairman and CEO of FHC. "we have a doubtlessly faster and less costly direction to convey APP's inventive BPH product to market. This jumpstarts the mixed business's interesting future and entry into the proprietary pharmaceutical space."
In April 2016, FHC entered into a definitive merger agreement with APP. FHC believes that the proposed transaction with APP provides an dazzling probability to set up a new business with the potential to enhance both brief-term and lengthy-term stockholder value. the new company may have diverse items that supply alternatives for growth, while mitigating the chance associated with FHC being a single product business. the new business will encompass a ladies's fitness division so one can center of attention on increasing FHC's present, profitable enterprise, whereas beginning development of newly bought oncology belongings for breast and ovarian melanoma, and a men's fitness division, concentrated on the areas of benign prostatic hyperplasia, male infertility, sizzling flashes in men on prostate cancer therapy, gout and advanced prostate cancer, along side buyer fitness products for premature ejaculation and sexual fitness diet supplements. Following the company combination, the co mpany could be renamed Veru Healthcare Inc.
the total assembly agenda is specified in FHC's definitive proxy statement, which has been filed with the Securities and change commission (SEC) and mailed to all stockholders of listing as of July 28, 2016, the listing date for the particular assembly of FHC's shareholders to approve matters regarding the proposed merger.
About Tamsulosin DRS for the remedy of BPH
Overview - Tamsulosin DRS is a novel powder which makes use of a proprietary prolonged liberate method of the latest energetic ingredient in Flomax®, which is a frequent drugs for the treatment of BPH, also called growth of the prostate. drugs or tablets are difficult for 15% of guys over the age of 60 who've problem swallowing and the as much as 60% of guys in long run facilities who've difficulty swallowing as a result of definite clinical conditions. as a result of Tamsulosin DRS is a novel powder formula containing the active pharmaceutical ingredient in Flomax®, it would give a easy and authentic option to deliver therapeutic stages of tamsulosin to men who've difficulty swallowing pills or tablets.
Market - The initial advertising plan will goal men in long term care amenities and guys within the neighborhood that have issue swallowing capsules and pills. at first a sales drive isn't required for this product as pharmacists and physicians have the means to establish and to deliver the applicable system of tamsulosin for a affected person who has BPH and issue swallowing tablets and pills. in keeping with IMS statistics Flomax® and widespread tamsulosin revenue from March 2014 to March 2015 had been about $three.5 billion within the U.S. The U.S. marketplace for all alpha blockers for BPH is estimated to be $4.5 billion yearly per IMS. men in long run care or nursing homes have up to a 60% incidence of swallowing difficulties and account for approximately 13% of complete tamsulosin earnings, whereas over 15% of men over 60 years of age in the commonplace population have problem swallowing tablets and capsules.
About Aspen Park pharmaceuticals
Aspen Park prescription drugs, Inc. is a privately held therapeutics enterprise focused on the construction and commercialization of pharmaceutical and client fitness products for men's and ladies's fitness and oncology. For men, product and product candidates are within the areas of benign prostatic hyperplasia, male infertility, amelioration of aspect outcomes of hormonal prostate melanoma healing procedures, gout, sexual dysfunction, and prostate melanoma. for women, product candidates are for superior breast and ovarian cancers and for feminine sexual fitness. Aspen Park prescription drugs is planning to launch within the united states the PREBOOST™ OTC product for treating premature ejaculation in q4 of fiscal 2016. Aspen Park prescribed drugs has workplaces in big apple city, ny. For extra advice on PREBOOST™ OTC product seek advice from www.preboost.com or for more assistance on APP seek advice from www.aspenparkpharma.com.
concerning the female health company
The female health business, based mostly in Chicago, Illinois, manufactures and markets the FC2 female Condom® (FC2). due to the fact the enterprise all started distributing FC2 in 2007, the product has been shipped to 144 international locations. The business owns definite global rights to the FC2 feminine Condom®, including patents that have been issued in a few international locations world wide. The patents cowl the key facets of the FC2 manufacturing method and design. The FC2 female Condom® is the simplest at present attainable feminine-managed product authorized by means of the FDA that presents twin coverage against sexually transmitted infections, including HIV/AIDS, the Zika virus and unintended pregnancy. the world health firm has cleared FC2 for buy with the aid of U.N. organizations.
ahead-searching Statements
This press free up carries ahead-searching statements, together with those related to the proposed merger transaction between FHC and APP and the combination of our two companies and people involving the timing and manner for regulatory approval of APP's Tamsulosin DRS. These statements are subject to frequent and unknown risks, uncertainties and assumptions, and if the sort of dangers or uncertainties materialize or if any of the assumptions prove unsuitable, our specific consequences might fluctuate materially from those expressed or implied by means of such statements. These dangers and uncertainties consist of but don't seem to be constrained to: the chance that the proposed transaction may additionally not be achieved in a timely manner or at all; the satisfaction of conditions to completing the transaction, together with the means to comfy approval with the aid of a two-thirds vote of FHC's shareholders; dangers that the proposed transaction might disrupt present plans and o perations; expenses, prices and fees concerning the proposed transaction; hazards related to the construction of APP's product portfolio, including regulatory approvals and time and price to convey to market; risks concerning the potential of the combined business to acquire sufficient financing on suitable phrases when obligatory to fund construction and business operations; the chance that, in spite of the fact that it's accomplished, we may now not understand the anticipated benefits from the transaction; and different dangers described in FHC's filings with the SEC, including our Annual file on form 10-ok for the yr ended September 30, 2015 and our Quarterly studies on form 10‑Q for the quarters ended December 31, 2015, March 31, 2016 and June 30, 2016. These files can be found on the "SEC Filings" component of our web page at http://fhcinvestor.com. All ahead-searching statements are in keeping with information accessible to us as of the date hereof, and FHC does not count on any duty and does not intend to replace any ahead-looking statements, apart from as required by means of legislation.
more information concerning the Proposed Transaction and where that you would be able to discover It
FHC filed a definitive proxy remark with the SEC regarding a solicitation of proxies from its shareholders in reference to a distinct meeting of shareholders of FHC to be held for the intention of vote casting on matters regarding the proposed transaction. before MAKING ANY vote casting resolution WITH admire TO THE PROPOSED TRANSACTION, FHC protection HOLDERS ARE urged TO study THE PROXY statement AND other vital materials once they turn into purchasable as a result of they are going to comprise crucial information in regards to the PROPOSED TRANSACTION.
The proxy remark and different principal materials, and another documents filed by FHC with the SEC, can be obtained free of can charge on the SEC's web page at www.sec.gov. additionally, shareholders of FHC might also acquire free copies of the files filed with the SEC by way of contacting FHC's Chief financial Officer at (312) 595-9123, or by means of writing to Chief monetary Officer, The female fitness enterprise, 515 North State road, Suite 2225, Chicago, Illinois 60654.
For more counsel about the female fitness company visit the enterprise's website at http://www.femalehealth.com and http://www.femalecondom.org. if you want to be introduced to the business's electronic mail alert record, please ship an email to FHCInvestor@femalehealthcompany.com.
Contacts: Michele Greco312-213-9859 Mitchell Steiner, MD 901-581-5872
No comments:
Post a Comment