Monthly Archives: March 2012

Piedmont Pharma and Hisun Sign Agreement to Develop Animal Pharmaceuticals

Collaboration also projected to benefit partnering animal health companies worldwide

NEW YORK, March 15, 2012 /PRNewswire/ — Piedmont Pharmaceuticals, a privately held strategic pharmaceutical development, licensing, and marketing company headquartered in Greensboro, N.C., USA, and Zhejiang Hisun Pharmaceuticals (SSE stock code 600267), a leading Chinese pharmaceutical company headquartered in Zhejiang, China, announce the signing of a joint agreement to develop companion animal health pharmaceuticals for China and other markets worldwide.

“New products are the lifeblood of every pharmaceutical company,” says Roland Johnson, chairman and CEO of Piedmont Pharmaceuticals. “Hisun is a globally-recognized pharmaceutical provider that demonstrates excellence in every facet of their business operations. This partnership will allow the team at Piedmont to develop and bring even more innovative animal health products to strategic business partners and pet owners worldwide.”

Hua Bai, CEO and chairman of Hisun Pharmaceuticals, notes, “Hisun is very pleased to enter this partnership with Piedmont Pharmaceuticals. The Piedmont team has tremendous depth of expertise and 25 years of proven success with some of the most successful animal health products ever introduced. This product development agreement is a significant component of our strategy to become a leading global supplier of animal health pharmaceuticals. Products emerging from this collaboration will not only help Chinese consumers ensure the health of their pets, but will serve pet owners in other global markets as well.”

Serving a growing market

Current estimates place China’s pet population at 200 million, with that number expected to reach 500 million by 2015.[i] China is the world’s second largest economy behind the U. S., and in the last 30 years, economic growth in China has averaged 8 percent gross domestic product (GDP) annually.[ii] Many analysts predict that China will become the largest economy in the world this century.

Combining strengths

Formed by a group of industry veterans, Piedmont Pharmaceuticals develops and achieves regulatory approval for its innovative animal health and human products, then licenses them to strong commercial partners. Piedmont has licensed a number of its novel animal health products to U.S.-based Pfizer, U.K.-based Dechra Pharmaceuticals, and Germany-based Bayer Animal Health.

Based on sales revenues, members of Piedmont’s team have been involved at some level — including conception, development, regulatory, or marketing — with products that represent more than 10 percent of total dollars spent in the companion animal veterinary pharmaceuticals market in the U.S. today.

Hisun supplies active pharmaceutical ingredients (APIs) to some of the world’s largest pharmaceutical companies, including Pfizer, Merck, Novartis, Eli Lilly, and Alpharma.[iii] In February 2011, Hisun entered into a joint venture framework agreement with Pfizer, the world’s largest pharmaceutical company, to develop products for human health.

Piedmont and Hisun will combine their strengths in research, development, regulatory, manufacturing, and distribution to improve the health and well-being of companion animals worldwide. Committed to meeting the manufacturing needs of its global expansion policy, Hisun currently has more than 200,000 square feet of new space under construction at the Fuyang site in China, including 35,000 square feet dedicated to the new animal health business.

About Hisun

Hisun is a leading biopharmaceutical group focused on improving patient wellbeing and quality of life. Headquartered in Taizhou (Zhejiang, China), the company currently employs more than 3,800 people. Hisun’s operations strictly follow cGMP and received ISO 14000 certification in 2001. To date, more than 40 of the company’s products have passed certification by the FDA (US), EDQM (EU), TGA (Australia), KFDA (Korea), etc., and are sold in more than 30 countries. The company opened its U.S. headquarters in Princeton, N.J., in 2010. For more information, visit www.hisunusa.com.

About Piedmont

Piedmont Pharmaceuticals LLC is a Greensboro, N.C.-based strategic pharmaceutical development and licensing company focused on human and animal health therapeutics with specific expertise in parasitology and drug delivery systems. The company discovers, develops, and achieves regulatory approval for innovative animal health and human health products, and then licenses them to strong commercial partners. Since its inception in 2001, Piedmont has licensed multiple novel patented delivery platforms to strategic partners. Through licensing agreements, Piedmont has products currently marketed in numerous countries. For more information, visit www.piedmontpharma.com.

[i] China International Business, January 19, 2010.
[ii] Economy Watch, June 2010.
[iii] www.KnowledgeAtWharton.com.cn, January 30, 2008.

Source: http://www.bizjournals.com/triad/prnewswire/press_releases/North_Carolina/2012/03/15/CL70333

ContraVac SpermCheck Male Fertility Tests Available in Stores

By Timothy W. Martin

Even when couples are grappling with infertility, many men balk at getting their sperm count checked. Now, an over-the-counter product enables them to check their count without a trip to the doctor.

SpermCheck Fertility promises to spot potential problems with male fertility in just about 10 minutes, potentially avoiding unneeded visits by women to the gynecologist or obstetrician, according to its owner and distributor, ContraVac Inc., a biotechnology start-up in Charlottesville, Va.

The company says it offers men the same kind of quick test women have access to with pregnancy or ovulation tests. “There’s now some gender equality on the family planning shelf,” said John C. Herr, a University of Virginia cell biology professor who came up with the product’s concept and helped in its development with a team of university staff.

More than seven million couples report having infertility issues every year, according to the Centers for Disease Control and Prevention. And about one-third of infertility cases are the result of male issues, with another third female, according to the agency. (The remaining third of infertility cases are caused by a combination of male and female problems or are unknown.)

Family planning products are a $250 million industry, dominated for now by ovulation-prediction and pregnancy-test kits, according to SymphonyIRI Group, a Chicago-based market-research firm.

After winning approval from the Food and Drug Administration, ContraVacbegan selling the kits in recent months online, through the websites of drug chains Walgreen Co. and CVS Caremark Corp. Walgreen plans to sell SpermCheck at its stores for $39.99 starting in mid-April.

ContraVac says the tests are 98% accurate, based on independent tests that were submitted to the FDA. Still, urologists caution that SpermCheck only measures one potential cause of male fertility. Sperm count “is just one of several parameters that’s looked at when we look at male fertility,” said Arthur Tarantino, president of the American Association of Clinical Urologists, adding male infertility could also occur due to the sperm’s movement or shape.

And while SpermCheck was FDA-approved to identify any sperm count lower than 20 million sperm per milliliter, the World Health Organization recently revised its standard, identifying any sperm count lower than 15 million sperm per milliliter as low. Most men, however, are capable of producing up to 300 million sperm per milliliter, so the lowered standard is “statistically extremely small,” Mr. Herr said.

Most semen analysis conducted by doctors costs between $100 and $250, though most health plans cover the test, according to urologists.

SpermCheck works by taking a semen sample and adding a solution that extracts “SP-10” protein found only in the coating of the sperm’s head. The concentration of the protein is proportional to a man’s sperm level. Within seven minutes, a line appears on the test kit if the sperm level is normal—not unlike a pregnancy test.

ContraVac Chief Executive Ray Lopez expects women—not men—to be the main purchasers of the product at stores. “She’s in there anyway, looking at the pregnancy test, wondering: ‘Hmm, why don’t I spend $40 and see if my man’s got an issue,’ ” Mr. Lopez said.

David Denison, a 30-year-old project manager from Greensboro, N.C., had been reluctant to get tested at a doctor’s office, so he bought SpermCheck online.

“The nice thing about this is that nobody knows you’re doing it,” said Mr. Denison, who said he would not feel awkward buying the test at a drugstore. The at-home product also allowed him flexibility in his schedule.

Source: http://online.wsj.com/article/SB10001424052702304450004577277732780865786.html