Tuesday, a panel of advisers recommended that the Food and Drug Administration (FDA) no longer support the marketing of calcitonin salmon as a treatment for post-menopausal women with osteoporosis.

The panel advised against the long-established bone strengthening drug due to the lack of evidence that it actually works, as well as its potential link to an increased risk of cancer. The panel voted 12-9 that the benefit of the calcitonin salmon products is outweighed by risks.

Calcitonin salmon is a man-made version of the hormone calcitonin, which is found in salmon. The drug has been prescribed for osteoporosis in postmenopausal women since 1984. Currently, Novartis’ Miacalcin injection and nasal spray and Unigene Laboratories Inc’s Fortical nasal spray distributed by Upsher Smith Laboratories in the US are approved for this indication. Additionally, there are generic versions of calcitonin products available.

The panel said that the drug has shown limited effectiveness in treating osteoporosis of women five years after menopause, and voted 20-1 that companies developing new calcitonin salmon products must prove their effectiveness in reducing fracture risk. Originally, the FDA approved these drugs based on surrogate endpoints, or initial measure that suggested the drug would make improvements in patient health.

After two recent studies showed patients taking the drug demonstrated a slightly higher rate of cancer, health authorities worldwide have been reviewing the drug’s safety. Last July, the European Medicines Agency decided that the drug should no longer be used for treatment of osteoporosis.

Due to the recent safety concerns with these products, prescriptions from 2006 and 2011 fell 51 percent to 205,000.

The FDA is not required to take the advice of the panel members, however often times does.

Source: Food and Drug Administration

Last Updated: 3/6/13; 11:00AM EST

MINNEAPOLIS--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced results from a Phase II trial for odanacatib, an investigational cathepsin K (cat-K) inhibitor in development for the treatment of osteoporosis in post-menopausal women. The results were presented today at the 34^thAnnual Meeting of the American Society for Bone and Mineral Research.

In the study, treatment with odanacatib (compared to placebo) significantly increased Bone Mineral Density (BMD) over a two-year period in post-menopausal osteoporotic women who previously had three or more years of treatment with alendronate. Patients were allowed to have been off alendronate therapy for up to three months immediately prior to enrollment in the study.

“Odanacatib works differently than other treatments for osteoporosis by targeting cat-K, a specific enzyme within bone cells,” said Albert Leung, M.D., Ph.D., executive director, clinical research, Merck Research Laboratories. “We’re excited about these results because understanding the effects of odanacatib in a population of post-menopausal women previously treated for osteoporosis is important to clinicians.”

Study evaluated efficacy and safety of odanacatib following treatment with alendronate

This study was a randomized, double-blind, placebo-controlled, multi-center, 24-month trial of odanacatib in 243 women with post-menopausal osteoporosis who had been previously treated with alendronate (dosed daily or weekly) for ≥3 years. Participants were at least 60 years of age with low BMD T-scores (≤–2.5 and >-3.5) at any hip site (femoral neck, trochanter, or total hip) without a history of fragility fracture, or had BMD T-scores ≤-1.5 and > -3.5 at any hip site, with a history of fragility fracture (except hip fracture). The patients were randomized in a 1:1 ratio to receive odanacatib 50 mg once weekly or placebo for 24 months. All patients received vitamin D3 (5600 IU/week) and also calcium supplementation, if needed.

The study evaluated the effects of odanacatib 50 mg once weekly on the following:

• · Femoral neck BMD change from baseline compared to placebo over 24 months (primary endpoint)

• · Femoral neck BMD compared to baseline over 24 months (key secondary endpoint)

• · BMD at hip trochanter, total hip, lumbar spine and distal forearm

• · Biochemical markers of bone resorption and formation at months 12 and 24

• · Clinical and laboratory assessment of safety and tolerability

BMD was assessed by DXA at baseline, 6, 12 and 24 months. This study was not designed to evaluate the effect of odanacatib on fractures.

Results showed odanacatib significantly increased BMD compared to placebo 

In the odanacatib group, BMD changes from baseline at 24 months were significantly different versus placebo at all three hip sites (+1.73%, +1.83%, +0.83% for the femoral neck, hip trochanter, and total hip, respectively, vs. -0.94%, -1.35%, -1.87% with placebo), and the lumbar spine (+2.28% vs. -0.30% change with placebo). At the distal forearm, BMD changes from baseline at 24 months were -0.92% and -1.14%. The difference versus placebo at the distal forearm (+0.22%) was not statistically significant.

The overall incidence of adverse events, including those that were considered drug-related or serious, were similar between treatment groups. Treatment discontinuations due to adverse events were 9.0 percent for patients receiving odanacatib and 3.3 percent for patients receiving placebo. The most common clinical adverse events in patients receiving odanacatib and placebo, respectively, were urinary tract infection (11.5%, 16.5%), back pain (11.5%, 9.9%), arthralgia (9.0%, 9.9%), fractures (4.9%, 13.2%), bronchitis (5.7%, 4.1%), nasal pharyngitis (3.3%, 5.8%), and upper respiratory infection (4.1%, 0.8%).

About Odanacatib

In osteoporosis, bone loss occurs because of an imbalance in bone remodeling (the rate of bone resorption exceeds that of bone formation). Osteoclasts, cells that resorb bone, secrete signaling factors to stimulate osteoblasts, cells that form bone. Odanacatib selectively inhibits cat-K, the primary enzyme in the osteoclasts that digests proteins during bone resorption. Progressive increases in bone mineral density have been demonstrated with odanacatib.

In July 2012, Merck announced it planned to begin closing the Phase III trial assessing fracture risk reduction with odanacatib, at the recommendation of the study’s Data Monitoring Committee (DMC), after its first planned interim analysis showed robust efficacy and a favorable benefit-risk profile. The DMC noted that safety issues remain in certain selected areas and made a recommendation with respect to following up on them. Merck's previously announced plan to conduct a blinded extension trial will allow further monitoring of the issues. The extension trial will also continue to measure efficacy.

Final results of the study will be submitted for presentation and publication in 2013 once the data analysis is complete. Merck anticipates submitting regulatory applications for odanacatib in the United States and European Union (EU) in the first half of 2013, and in Japan in the second half of 2013.

About Merck

Today's Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies, and consumer care and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. For more information, visit www.merck.com and connect with us on Twitter, Facebook and YouTube.

Forward-Looking Statement

This news release includes “forward-looking statements” within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Such statements may include, but are not limited to, statements about the benefits of the merger between Merck and Schering-Plough, including future financial and operating results, the combined company’s plans, objectives, expectations and intentions and other statements that are not historical facts. Such statements are based upon the current beliefs and expectations of Merck’s management and are subject to significant risks and uncertainties. Actual results may differ from those set forth in the forward-looking statements.

The following factors, among others, could cause actual results to differ from those set forth in the forward-looking statements: the possibility that all of the expected synergies from the merger of Merck and Schering-Plough will not be realized, or will not be realized within the expected time period; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; Merck’s ability to accurately predict future market conditions; dependence on the effectiveness of Merck’s patents and other protections for innovative products; and the exposure to litigation and/or regulatory actions.

Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Merck’s 2011 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

SAN ANTONIO, Oct. 11, 2012 /PRNewswire/ -- Mission Pharmacal Company today announced that BINOSTO™ (alendronate sodium) Effervescent Tablet for buffered oral solution (70 mg) is now available by prescription in the United States.  The U.S. Food and Drug Administration has approved BINOSTO to treat osteoporosis in postmenopausal women and to increase bone mass in men with osteoporosis.

BINOSTO delivers easy-to-swallow osteoporosis treatment and fracture prevention at the hip and spine -- alendronate sodium -- in a once weekly, buffered solution.  BINOSTO represents a true innovation in the delivery of osteoporosis and bone fracture prevention medication, especially for those patients who prefer not to swallow tablets, suffer with dysphagia, or have other medical difficulties swallowing pills.

"We are very pleased to add BINOSTO to our line of bone health products," says Terry Herring, President of Commercial Operations at Mission Pharmacal.  "With this exciting new treatment option, physicians can rest easily, knowing they are prescribing an easy-to-take and proven therapy for their osteoporosis patients that protects against fracture risk at the hip and spine."

Although osteoporosis is often thought of as a disease which impacts mostly women, it affects men as well.  While women do suffer relatively rapid bone loss in the first few years after menopause, it should be noted that by about age 65, men and women lose bone mass at the same rate.ⁱ

With one of every two postmenopausal women at risk for an osteoporosis fracture, osteoporosis affects more than 200 million women and men worldwide and more than 10 million people in the United States, yet the gravity of the disease is often underestimated.  According to an article published in the December 6, 2011, issue of the Annals of Internal Medicine, a woman's lifetime risk of dying from hip fracture is similar to her risk of dying from breast cancer.ⁱⁱ

"Osteoporosis is widespread, with serious consequences for patients, including mortality which is often seen after suffering a hip fracture.  In fact, up to 24 percent of patients with a hip fracture end up dying from complications within 12 months.  And, unfortunately, many people incorrectly consider osteoporosis to be a normal part of aging.  That's because it is largely asymptomatic,"ⁱⁱⁱ said Sol Epstein, MD, professor of medicine and geriatrics at Mount Sinai School of Medicine in New York. "But osteoporosis is treatable.  With the many new treatment options available, there is no reason for women to suffer the loss of independence and the pain and even mortality associated with osteoporotic fractures."

For anyone with osteoporosis, the best protection against suffering from a fracture is taking medications as prescribed by an authorized healthcare provider.  However, studies show that people who have trouble swallowing pills are much more likely to stop taking their medication.  Taken just once a week, strawberry flavored BINOSTO is a buffered effervescent solution that can help patients with swallowing difficulties be more compliant and decrease the risks of disabling fractures.

About BINOSTO
BINOSTO is a once weekly, strawberry flavored effervescent tablet containing alendronate (70mg) that rapidly dissolves in half a glass (4 oz.) of plain room temperature water to make a buffered solution.  BINOSTO is available in packs of four.  The national drug code number is 0178-0101-02.

BINOSTO was developed by EffRx based on an agreement with Merck & Co, Inc. granting EffRx the worldwide rights to all effervescent and related patents of FOSAMAX^®(alendronate).  Patents have been granted to EffRx providing exclusivity for BINOSTO through February 2023.  Additional patents are pending.

About Mission Pharmacal Company
Mission Pharmacal is a privately held pharmaceutical company based in San Antonio, Texas.  For more than 65 years, the company has been committed to meeting the unique healthcare needs of women throughout all stages of life, pediatric patients, and those persons dealing with urologic and dermatologic conditions.  The company has a proven track record of identifying unmet healthcare needs and developing both innovative prescription and over-the-counter products to meet these needs.  Using only the purest ingredients, Mission Pharmacal provides physicians and consumers with the highest quality pharmaceutical and dietary supplement products on the market today.  Mission Pharmacal is a proud national supporter of the March of Dimes Foundation, whose mission is to improve the health of babies by preventing birth defects, premature birth, and infant mortality.  For more information about the company, visit www.missionpharmacal.com.

About EffRx
EffRx Pharmaceuticals SA is a drug delivery company based in Freienbach, Switzerland.  EffRx specializes in improving existing high volume pharmaceutical products by utilizing its novel techniques in different effervescent executions.  The primary focus of EffRx is in metabolic bone disease, oncology supportive care, pediatric medications, and support to larger companies in Life Cycle Management.  For more information about the company, visit www.effrx.com.

ⁱ https://annals.org/article.aspx?articleId=1033214

ⁱⁱ http://www.niams.nih.gov/Health_Info/Bone/Osteoporosis/men.asp

ⁱⁱⁱ http://www.endo.theclinics.com/?vote=true

SOURCE Mission Pharmacal

The Food and Drug Administration (FDA) recently expanded indication for Amgen’s bone building drug Prolia (denosumab) to increase bone mass in men who have osteoporosis and are at high risk for fracture.

Prolia is the first FDA approved RANK Ligand inhibitor, which is a subcutaneous injection administered every six months. The indication is based off of results from the ADAMO trial, which compared efficacy and safety of denosumab 60mg versus a placebo for male patients with osteoporosis.

“While osteoporosis and osteoporosis-related fractures are more commonly associated with postmenopausal women, osteoporosis in men is a significant issue that is increasing in prevalence as life expectancies rise,” Sean E. Harper, MD, executive vice president of Research and Development at Amgen said in a news release.

The 12-month study consisted of 242 men with low bone mineral density (BMD). They found that treatment with Prolia had a 5.7 percent gain at the lumbar spine than compared to 0.9 for patients receiving the placebo. They also found that patients receiving the drug experienced an increase in BMD in all other skeletal sites evaluated than those on the placebo.

Common reported adverse events were back pain, arthralgia and nasopharyngitis.

According to the National Osteoporosis Foundation, in the US there are roughly two million men with osteoporosis and 12 million who are at risk.

For more information on Prolia visit: http://www.prolia.com

Source: Amgen

Last Updated: 9/26/12; 11:40AM EST