News

Japan approves first generic biotech drug

Reuters - Japanese regulators approved a human growth hormone from Novartis AG, the first green light in Japan for a biosimilar or generic version of a biotech drug, the Swiss drugmaker said on Thursday.

Biosimilars are viewed as a promising new market, given the pent-up demand for cheaper versions of extremely expensive biotech drugs, some of which are coming to the end of their patent life.

Somatropin, made by Novartis' generics unit Sandoz, is for treatment of growth hormone deficiency in children and growth disturbance associated with Turner's syndrome or chronic renal insufficiency, the group said.

The approval is for the same range of diseases as the reference product, Pfizer Inc's Genotropin, Novartis said. The drug is already approved in Europe and the United States as Omnitrope.

Biotech drugs, used to treat everything from cancer to autoimmune diseases such as rheumatoid arthritis, tend to be more expensive and complex than traditional chemical medicines because they are made from living cells.

Conventional drugs can lose up to 90 percent of their sales within a year once they face generic competition. But relatively few companies are now capable of making biosimilars.

Brand-name biotech companies such as Roche Holding AG's Genentech Inc and Amgen Inc say they need an adequate period without competition to encourage development of new medicines.

Novartis shares fell 1.0 percent to 45.04 Swiss francs by 0827 GMT (4:27 a.m. EDT), in line with the DJ Stoxx European healthcare index.

The first biosimilars have already been approved and are on the market in Europe. The United States, the world's biggest and most lucrative pharmaceuticals market, is still discussing a regulatory pathway for follow-on biotech treatments.

Drugs industry supplier Lonza Group Ltd believes it is tough to predict the size of the market because of uncertainty of how regulations will end up, its chief executive Stefan Borgas said earlier this month.

“I think common wisdom at the moment is that the global biologics market is something like $80-90 billion, and what the price reduction will be is a bit of a crystal ball discussion at the moment,” Borgas told Reuters.

“Even if the most optimistic forecast is too optimistic, it will be a significant market. In the billions and the 10s of billions.”

(Editing by Mike Nesbit and David Holmes)

Women's Sexual Health Issues Hit Home

HealthDay News — A new survey finds that 70 percent of American women have experienced a sexual health issue, and 22 percent felt very or extremely concerned about it.

The survey defined a sexual health issue as any one of the following conditions: lack of desire for sexual activity, inability to become sexually aroused, inability to have an orgasm, pain during intercourse, vaginal dryness, or excessive desire for sexual activity.

Women who reported a sexual health issue said it had an effect on their romantic relationships (44 percent), self-esteem (43 percent) and mental health (42 percent). Sexual health issues also caused stress and anxiety in 66 percent of those surveyed, and affected sleeping habits in 28 percent and weight in 25 percent, the researchers found.

When they wanted to get information about sexual health issues, 35 percent used the Internet and 32 percent turned to their partner. While many women said they'd be comfortable discussing a sexual health issue with a health-care provider, only 18 percent actually saw a health-care provider when they had a sexual health issue, the findings showed.

The survey, released Thursday, was commissioned by the National Women's Health Resource Center (NWHRC) and the Association of Reproductive Health Professionals (ARHP). The survey was sponsored by Boehringer Ingelheim Pharmaceuticals Inc.

“Given the number of women who experience sexual health issues, it is important to provide them with accurate, unbiased information on conditions they may encounter throughout their lifetime,” Elizabeth Battaglino Cahill, executive director of the NWHRC, said in a news release from the center.

“Fortunately, many sexual health issues can be successfully addressed through education, lifestyle changes, counseling and treatment, and we encourage women to talk with their partner and their health-care provider,” Cahill said.

“Health-care providers today have more resources than ever to help women understand and maximize their healthy sexuality throughout the age span,” noted Dr. Beth Jordan, medical director of the ARHP. “It is critical for women to understand the basics of female sexual response and the myriad, and often emotional, factors that impact their sense of sexuality.”

Drug deals cost U.S. consumers $3.5 bln a year: FTC

Reuters - Consumers, insurance companies and the federal government spend an extra $3.5 billion for prescription drugs every year because brand-name companies pay generic producers to stay out of the market, the head of the U.S. Federal Trade Commission said on Tuesday.

FTC chief Jon Leibowitz urged Congress to pass legislation, now pending in the U.S. Congress that would ban deals in which brand-name drug makers pay generic companies to delay production of cheaper versions of popular drugs.

“Eliminating these deals is one of the Federal Trade Commission's highest priorities,” Leibowitz said at the Center for American Progress, a think tank.

While a member of the U.S. Senate, President Barack Obama co-sponsored an earlier version of the legislation.

The FTC estimated that the federal government pays about one-third of all prescription drug costs, so eliminating “pay for delay” settlements would save the government $1.2 billion annually.

The FTC has challenged the deals in court, saying patent settlements were sometimes used to disguise payoffs that kept generic versions of drugs off the market. The agency has had mixed results in the courts.

The first known “pay for delay” was in 1994 when Bristol-Myers Squibb Co paid $290 million to Schein Pharmaceutical to delay the sale of a generic version of Bristol's anxiety drug Buspar.

The FTC has calculated that consumers could save even more if generic companies were allowed to make copies of expensive biotechnology drugs, something the U.S. Food and Drug Administration does not now allow.

(Reporting by Julie Vorman and Diane Bartz; editing by John Wallace)

U.S. lawmakers tussle over generic biologic drugs

Reuters - U.S. lawmakers tussled on Thursday over how long makers of biotechnology drugs should have an exclusive license for the expensive medicines in a hearing called to discuss a Federal Trade Commission report on the issue.

The FTC, which specializes in antitrust and consumer welfare, had concluded that passing a law allowing generic medicines for biotechnology drugs would create some savings for consumers but not the huge amounts that patients save by buying generic versions of some antibiotics and other, simpler drugs.

Democratic Representative Henry Waxman, who sponsored the original legislation creating generic drugs and is sponsoring a bill to allow five years of exclusivity for original biotech products, took issue with drug industry arguments for longer periods without competition.

“The drug industry has been engaged in a massive and expensive lobbying campaign to convince the members of this committee that the supply of life-saving drugs will dry up if they don't get triple the monopoly protection available to all other drugs,” said Waxman, chairman of the Committee on Energy and Commerce.

He told the committee's health subcommittee that he had seen “little or no persuasive evidence” to support industry claims that biotech companies need 12 to 14 years of exclusivity to break even.

Representative Anna Eshoo, a Democrat, disagreed and objected to the hearing for failing to bring scientific experts in to discuss the safety and effectiveness of the generics. “I'm puzzled and somewhat disappointed by the subcommittee's approach,” said Eshoo, who was honored last July as the Biotechnology Industry Organization legislator of the year,

Biologic drugs — which are usually injectable — tend to be more complicated than traditional chemical medicines because they are made from living cells. Their generic versions will require a more complicated approval pathway than simpler chemical-based drugs.

Biologic medicines are used to treat everything from cancer to autoimmune diseases such as rheumatoid arthritis.

Representatives Marsha Blackburn, a Republican, and Tammy Baldwin, Democrat, expressed concern that the biotechnology companies in their districts would be unable to recoup the millions they invested in developing the complex drugs if generic versions came to market too soon.

“I will tell you I am very concerned about protecting the intellectual property of that industry,” said Blackburn.

Brand-name biotech companies such as Roche Holding's Genentech Inc and Amgen Inc say they need an adequate period without competition to encourage development of new medicines.

The generic drug industry is eager to begin producing cheaper copies of the medicines.

The FTC report, which the pharmaceutical groups roundly criticized, concluded that competitors would likely enter the market only for drugs that had more than $250 million of annual sales, and only two to three generic entrants would be expected for each drug.

This means prices would likely drop just 10 to 30 percent while the first manufacturers would likely retain 70 to 90 percent of their market share, the FTC said.

(Reporting by Diane Bartz; Editing by Steve Orlofsky)

Antibiotics for bacterial vaginosis

Examples

Cleocin [oral, vaginal], Clindesse [vaginal]
Flagyl [oral], MetroGel-Vaginal
Tindamax [oral]

These antibiotic medicines can be taken by mouth in pill form (orally) or inserted into the vagina in cream, gel, or suppository form (ovules). Vaginal creams and gels are used with an applicator that inserts the correct amount of medicine. (Tinidazole is only taken by mouth.)

Oral or vaginal metronidazole for 7 days is the first-choice medicine for treating bacterial vaginosis. 1, 2

How It Works

Metronidazole, clindamycin, and tinidazole are antibiotics that destroy some of the bacteria that cause symptoms of bacterial vaginosis.

Why It Is Used

Oral medicine

Some women prefer oral medicine rather than vaginal administration.

Especially for pregnant women who are high-risk for preterm labor, only oral medicines are used to treat bacterial vaginosis. Some doctors recommend that all pregnant women avoid vaginal treatment.

Vaginal medicine

Vaginal medicines are less likely than the oral forms to cause systemic side effects, such as nausea and vomiting.

How Well It Works

Women who aren't pregnant

For bacterial vaginosis treatment, the Centers for Disease Control and Prevention (CDC) recommends oral metronidazole for 7 days or vaginal metronidazole gel for 5 days, as they are equally effective. 2 Metronidazole offers average cure rates of 80% to 90%. Also, metronidazole is thought to be most effective for treating infection that has spread into the upper reproductive tract. But bacterial vaginosis recurrence is common. If the infection has been treated successfully, some doctors may prescribe metronidazole gel twice weekly for a few months. This keeps the infection from coming back.

The CDC also recommends clindamycin cream 2% for 7 days, while noting that it might not be as effective as metronidazole. 2 Clindamycin's relapse rate is higher: 4 weeks after clindamycin treatment, 56% of women have recurring bacterial vaginosis. 1 Clindamycin ovules are similarly effective. 2
Women who are pregnant

For bacterial vaginosis during pregnancy, the CDC recommends oral metronidazole or oral clindamycin for 7 days. 2 Some experts recommend clindamycin as a second choice because it may be less effective. 1

Side Effects

Vaginal medicines

Side effects of vaginal clindamycin and metronidazole are generally minor. The most common is a vaginal yeast infection during or after treatment.

The mineral oil in clindamycin cream or ovules can cause latex condoms or diaphragms to fail. This is also true for metronidazole cream and tablets (the gel is fine for use with condoms and diaphragms). Don't trust barrier methods of birth control when using this type of vaginal medicine.

Oral medicines

Oral treatment can cause:

* Unpleasant metallic taste in the mouth (common with metronidazole or tinidazole.).
* Nausea.
* Vomiting.
* Diarrhea.

Completely avoid alcohol use (including alcohol-based nonprescription medicines, such as NyQuil) while you are taking metronidazole or tinidazole, because combining alcohol with these medicines may cause severe nausea and vomiting.

What To Think About

During pregnancy

The Centers for Disease Control recommends treatment for bacterial vaginosis at any time during pregnancy. 2

Either oral metronidazole or oral clindamycin are used for treatment in the second and third trimester of pregnancy. Neither medicine is likely to cause any harm to the fetus. 2, 3 Tinidazole is not recommended for use during pregnancy.

* Metronidazole has been well studied and is generally thought to be safe to use during pregnancy.
* Use of clindamycin vaginal cream is not recommended for bacterial vaginosis treatment in pregnant women. The cream form of clindamycin has been shown to have a slightly increased risk for preterm birth. 3
* Tinidazole is not recommended for use during pregnancy.

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