VVUS, VIVUS, Inc.
** VVUS reported that the FDA has approved STENDRA (avanafil) tablets for the treatment of erectile-dysfunction (ED), marking the first new prescription agent approved in nearly a decade for the condition that afflicts as many as 30 million men in the U.S.
More than 1,200 men with ED participated in clinical studies evaluating the efficacy and safety of STENDRA. STENDRA at all doses tested (50mg, 100mg and 200mg) met all primary efficacy endpoints. Significant improvement in erectile-function was observed for all doses in STENDRA-treated patients compared to placebo.
Erectile-dysfunction (ED), affects an estimated 52% of men between the ages of 40 and 70. Prevalence increases with age and can be caused by a variety of factors, including medications (anti-hypertensives, histamine receptor antagonists); lifestyle (tobacco, alcohol use); diseases (diabetes, cardiovascular conditions, prostate cancer); and spinal cord injuries.
Left untreated, ED can negatively impact relationships and self-esteem, causing feelings of embarrassment and guilt. However, about half of men being treated with currently available PDE5 inhibitors are dissatisfied with treatment.
The market opportunity for ED medical treatments continues to grow, with worldwide sales of PDE5 inhibitors exceeding $5 billion in 2011.
VVUS is currently in discussion with potential partners to commercialize STENDRA in the United States and in its territories in the rest of the world.
STENDRA (avanafil) is licensed from Mitsubishi Tanabe Pharma Corporation. VVUS has development and commercial rights to STENDRA for the treatment of sexual-dysfunction worldwide with the exception of certain Asian Pacific Rim countries. In South Korea, STENDRA is approved and is marketed by JW Pharma under the brand name Zepeed.
VVUS is a biopharmaceutical company developing therapies to address obesity, sleep apnea, diabetes and male sexual-health.
More about VVUS at www.Vivus.com.
VSCI, Vision-Sciences, Inc.
** VSCI reported that it has entered into a purchase agreement with Lincoln Park Capital Fund, LLC (LPC), a Chicago-based institutional investor, for the sale of up to a total of $15 million of its common stock.
The purchase agreement commits LPC to purchase up to $15 million of VSCI's common stock, from time to time, over a 36-month period, subject to specified limitations, including an initial investment of $1 million.
The securities under this agreement are offered through a prospectus supplement pursuant to the Company's effective shelf registration statement and included base prospectus.
Under the agreement, there are no upper limits to the price LPC may pay to purchase VSCI's common stock. LPC has no right to require any sales by VSCI, but is obligated under the agreement to purchase the Company's common stock, as VSCI directs in its sole discretion as provided in the agreement. VSCI may terminate the agreement at any time, without cost or penalty.
The pricing of any sale of VSCI's common stock to LPC will be fixed pursuant to a formula based upon market prices of the Company's common stock preceding the notice to LPC without any fixed discount. VSCI will therefore know on the date it elects to sell stock to LPC the price per share that LPC will be required to pay.
VSCI designs, develops, manufactures and markets products for endoscopy ? the science of using an instrument, known as an endoscope, to provide minimally invasive access to areas not readily available to the human eye.
More about VSCI at www.visionsciences.com.
Internet advertising is huge, and basically has a huge market today. The internet has the ability to reach global audiences.
Crown Equity Holdings Inc. (CRWE.OB) offers advertising branding and marketing services as a worldwide online multi-media publisher with its digital network of websites and focuses on the distribution of information for the purpose of bringing together a targeted audience and the advertisers that want to reach them.
CRWE?s division CRWE AD-Services (www.crwe-adservices.com), is a full service multimedia advertising company specializing in internet marketing. It provides modern and unique advertising campaigns, dedicated to offering the most cost effective advertising solutions.
Since the World Wide Web is so widely available, with internet advertising, businesses can access millions of potential customers with just a few clicks.
CRWE?s advertising services cover and connect a range of marketing specialties, as well as provide search engine optimization for clients interested in online media awareness.
More about CRWE at www.crownequityholdings.com.
MRK, Merck & Co., Inc.
** MRK reported that the U.S. District Court for the District of New Jersey has ruled in MRK's favor in two jointly related patent infringement suits against Mylan Pharmaceuticals Inc.
The patent at issue in this trial is RE 42,461 which covers ezetimibe, an active ingredient in both ZETIA and VYTORIN and expires April 2017.
In its decision, the court upheld MRK's patent on ZETIA and VYTORIN and ruled that the patent was valid and enforceable. Mylan had admitted that its product would infringe the patent. The court also issued an injunction blocking the approval of Mylan's generic versions until the expiration of the patent.
Mylan had been seeking FDA approval to sell generic versions of ZETIA and VYTORIN. In December 2009, MRK filed the lawsuit against Mylan in respect of Mylan?s application to the FDA seeking pre-patent expiry approval to sell a generic version of VYTORIN and in June 2010, MRK filed a separate lawsuit against Mylan in respect of Mylan's application seeking pre-patent approval to sell a generic version of ZETIA.
For the first quarter 2012, MRK posted Zetia's sales of $614 million, and Vytorin's sales of $444 million.
MRK is a global healthcare leader working to help the world be well. MRK is known as MSD outside the United States and Canada.
More about MRK at www.merck.com
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