KV Pharm - Product
Company: KV Pharmaceutical, St. Louis, MO
Company Description: KV Pharmaceutical is a fully integrated specialty pharmaceutical company developing and marketing technology- distinguished branded and generic/non- branded prescription pharmaceuticals. The Company markets its products through ETHEX Corporation, a national leader in pharmaceuticals competing with branded products, and Ther-Rx Corporation, its branded drug subsidiary.
Nomination Category: Company, Office & Product Awards Categories
Nomination Sub Category: Best New Product or Service
Nomination Title: Ther-Rx's Clindesse™
1. Tell the story about this nominated product or service (up to 500 words). Describe its function, features, benefits, and sales to date. You may include hyperlinks to product photos and data sheets. IMPORTANT: Begin each link with http://, and enclose each link in square brackets; for example, [http://www.youraddress.com]:
Clindesse™, a single-dose vaginal cream antibiotic, for bacterial vaginos(BV), has proven to be the answer to multiple market needs that had been unmet in the years prior to its debut. By launching Clindesse™ in January 2005, Ther-Rx, the branded subsidiary of KV Pharmaceutical, provided physicians with a highly effective treatment and patients with convenience that had been previously unavailable. Moreover, a reduced cost burden on the U.S. healthcare system may be realized as untreated/uncured bacterial vaginosis can result in a myriad of obstetric and gynecologic complications, including pelvic inflammatory disease (PID) that may progress to infertility, as well as increased risk of HIV acquisition.
Historically, patient compliance with BV therapy has been a treatment obstacle for physicians. Patients do not want to take time out of their busy days for repeated doses, endure inconvenient products requiring applicator filling, cleaning and reuse, or be required to lie prone after administration (i.e., bedtime use). The market already had 5 competitors offering a variety of formulations (oral tablets and capsules, topical creams, ovules and a gel), utilizing one of two different antibiotics (metronidazole or clindamycin), and a range of 3, 5, 7, 10, or 14 dosing requirements. Clindesse™ entered the market as the only single-dose therapy, the only product offering exclusive bioadhesion technology, and an efficacy rate comparable to competitors. After administering, the patient has achieved compliance on their first (and only) use. Clindesse™ appeals to patients because it can be used anytime and anywhere – it is packaged in a prefilled applicator, and features a patented bioadhesion technology that helps keep the cream neatly in place, minimizing leakage that can occur with other topical treatments. A woman can administer Clindesse™ quickly and then continue with her activities.
For the physician, there is clinical proof that the efficacy of one-dose Clindesse™ is equivalent to 7 days of a key competitor, and that the product’s safety profile is similar to placebo. Further, the unique multi-port applicator assures the physician that the product is evenly distributed at the site of infection. Thus, the physician can be confident that the product will work, and that their patients will comply with the convenient treatment regimen, thus helping mitigate the risks of not treating the condition.
Given the features and benefits of Clindesse™, market uptake was rapid. Despite a competitive BV marketplace, Clindesse™ secured 20% market share, achieved sales of $27.5 million in the 14 months since launch, and continues to grow.
The Clindesse™ success story verifies that market need is being met since Clindesse™ treats bacterial vaginosis in one dose, provides physicians a safe and effective therapy option, and offers patients a convenient medication that does not impede their daily activities.
2. List hyperlinks to any online news stories, press releases, product reviews, or other documents that support the claims made in the section above. IMPORTANT: Begin each link with http://, and enclose each link in square brackets; for example, [http://www.youraddress.com]:
http://kvph.com/news/article.asp?id=208http://kvph.com/news/article.asp?
id=206http://kvph.com/news/article.asp?id=200
http://kvph.com/news/article.asp?id=186http://kvph.com/news/article.asp?
id=186http://kvph.com/news/article.asp?id=193
3. Provide a brief (up to 100 words) biography about the leader(s) of the team that developed this nominated product or service:
The development of Clindesse™ is an example of the team-oriented culture at KV Pharmaceutical. This product was developed through a collaborative effort lead by KV’s Discovery Research and Clinical Affairs Departments. The effort was supported by multiple other functional areas within the Company.