A joint meeting of the European Calcified Tissue Society and the International Bone and Mineral Society, held June 2005 in Geneva, Switzerland, revealed promising developments for more effective treatments in bone heath—specifically geared toward the “silent epidemic,” osteoporosis.

Five years later, on June 1, 2010, the FDA approved Amgen’s Prolia (denosumab), the first biologic medication for treatment of postmenopausal women with osteoporosis at high risk for fracture.

This decision came one year after the Agency originally delayed the drug’s approval. The reason cited: Amgen needed to show a new clinical program to support approval of the drug’s prevention indication.

They didn’t waste any time.

Commitment to Safety, Achievement
The company, with FDA’s aid, quickly developed a Risk Evaluation and Mitigation Strategy (REMS) to help patients understand the drug’s risks. The REMS included a communication plan for healthcare providers and a medication guide for patients, comprehensive post-marketing surveillance, and a post marketing Active Safety Surveillance Program to monitor the long-term safety of Prolia. In addition, Amgen set up a surveillance program to monitor more than 4,500 women who already were taking the drug.

And that’s just the beginning of a march forward. With these improvements came honorable mentions.

Not only was Prolia named one of Time magazine’s Top 10 medical breakthroughs of 2009 but it also won the Best New Drug award at the 2010 Scrip Awards. The Scrip judges highlighted Prolia’s efficacy in reducing fractures and dosing regimen.

A Bona Fide Answer to Osteoporosis
A scientific journey that started more than 15 years ago, Prolia is administered as an injective every six months to reduce risk of fracture at the spine, hip, and other sites. Normally, the body is charged to break down and rebuild bone as needed. Low estrogen levels in postmenopausal women unbalance this process in favor of bone breakdown. Prolia halts this process.

During its three-year study, 7,808 postmenopausal women ages 60 to 91 were put on a trial. The study (funded by Amgen) concluded Prolia reduced the incidence of vertebral, non-vertebral, and hip fractures in postmenopausal women with osteoporosis.

It should be noted that Prolia isn’t the first injectable osteoporosis drug, however. It’s a new type. Two bisphosphonate medications, Reclast and Boniva, are also delivered intravenously. Forteo and Miacalcin, require self-injections.

For patients intolerant to other available osteoporosis therapies, Prolia is the only FDA-approved RANK ligand inhibitor, an essential regulator of osteoclasts (the cells that break down bone)—and its sales are soaring as a result. The drug generated $9.95 million in sales from launch through September 2010, according to IMS Health.

Connecting Globally
The total direct medical cost of osteoporosis in Europe has been estimated at more than €36 billion annually, and is expected to increase to €76.7 billion in 2050. In May 2010, Prolia was granted marketing authorization in the EU—perhaps one of the more significant unique selling points of the drug. It is the first and only approved treatment in Europe for bone loss due to hormone ablation in men with prostate cancer.

Prolia’s European approval in all 27 EU member states, as well as Norway, Iceland, and Liechtenstein, led to the first approval of the product worldwide.

Only time will tell how the drug impacts patients who are seeking long-term relief. For now, Prolia is representing promising efforts of science—and pharma is standing proudly behind it.

It’s been less than three days since new broke of a massive earthquake in Haiti that all but leveled the struggling country. With thousands dead, a devastated infrastructure, and no emergency plan, countries and businesses around the world have joined in the effort to help the Haitian people with food, supplies, and money. Here’s what some pharma companies are doing to send relief to our neighbors.

“The recent earthquake has had a devastating impact on Haiti’s limited health care system, which was already facing significant challenges,” stated Catherine V. Babington, president, the Abbott Fund. “Building on our existing partnerships with humanitarian organizations in Haiti, we are providing funding and product donations to help address the immense and immediate health needs.”

• Teva Pharmaceuticals will be donating more than $7 million in medicine. Teva is working with several of its Non-Governmental Organization partners to ensure these drugs are delivered to Haiti without delay.
• King Pharmaceuticals donated $200,000 to the American Red Cross to help with its Haiti earthquake relief efforts.
• The Genentech Foundation committed $500,000 to support disaster relief. Here’s the break down: A grant of $200,000 to CARE will help provide  food, water and hygiene items to people in need. A grant of $200,000 to Mercy Corps will provide medical supplies  and support medical teams on the ground. A $100,000 grant to the American Red Cross International Fund will  go toward tarps, tents and other emergency housing items to provide shelter for  the millions left homeless.
• Sanofi-aventis has committed 1 million Euros in financial aid to long-term reconstruction initiatives and the rehabilitation of the population of Haiti.
• Pfizer pledged $1 million in product donations and $250,000 cash (to UNICEF and CARE). Additionally, Pfizer Canada is matching all employee donations up to $250.
• GSK donated $1.4 million in medicines to many different relief organizations, as well as $408,000 to the British Red Cross to treat water contamination.
• Bayer is providing medicines to the Red Cross to be distributed to earthquake victims. Additionally, the company is doubling employee donations up to EUR $100,000.
• Abbott announced on Wednesday that it would send $1 million $2.5 million in aid and medical products to Haiti. The first wave of support comes in the form of $100,000 in grants to the American Red Cross, Partners in Health, and Catholic Medical Mission Board.
• Lilly stated that it has pledged $250,000 in cash, half of which is being sent ASAP, and the other half will be staggered over the next year to help rebuild the country. The company will also match employee donations, up to $250,000.
• Amgen said that it would donate $2 million to the Haitian government to help bolster relief efforts. Additionally, the company will use its Disaster Relief Program Web site to help employees donate additional funds. All donations through the site will be matched by Amgen.

This list will be updated as we hear from other pharma companies. Please contact us at gkoroneos@advanstar.com if you know of a pharma company involved in the relief effort.

In an effort to boost its sales force without hiring more sales reps, Amgen announced on Tuesday that it has signed a deal with GlaxoSmithKline to co-market its osteoporosis treatment denosumab—currently pending FDA approval.

GSK will paying $120 million up front (along with royalties) to mutually market denosumab, or DMab, in regions where Amgen currently doesn’t have a strong sales force, such as China, India, and Brazil. The companies will tag team commercialization in Europe, Australia, New Zealand, and Mexico. Meanwhile, Amgen will handle all marketing in the United States and Canada.

“Our collaboration with GlaxoSmithKline will help Amgen bring the promise of denosumab to patients in Europe and other parts of the world more effectively than if we commercialized the drug globally on our own,” stated Amgen CEO Kevin Sharer in a release. “Amgen and GlaxoSmithKline together are uniquely positioned to help medical providers and patients understand the clinical promise and economic value of denosumab.”

Amgen is banking on denosumab being a blockbuster treatment, with analysts speculating that the drug could fetch $2 billion by 2018. The twice yearly injectible will go up against Merck’s daily osteo pill Fosamax, which went generic in 2007.