Perrigo buys KV Pharma filing for generic acne gel

Generic drugmaker Perrigo Co (PRGO.O) bought the marketing application of KV Pharmaceuticals Inc (KVa.N) (KVb.N) to market a copycat version of GlaxoSmithKline's (GSK.L) (GSK.N) acne treatment Duac for an upfront payment of $14 million.

Perrigo's move to buy the additional new drug application (ANDA) for the generic version gives the embattled drugmaker KV Pharmaceuticals its second respite this month.

On Sept. 2, the U.S. Food and Drug Administration, which had restrained KV Pharma from manufacturing and shipping any of its drugs, accepted the company's work plan to address previously identified deficiencies in manufacturing practices.

KV Pharma, which has taken up a slew of restructuring activities since the beginning of the year, had earlier expressed significant doubt about its ability to continue as a going concern during the coming fiscal year.

However, selling its marketing application for a copycat version of Duac, in a deal that included $2 million in milestone payments, also lifted off expenses from a lawsuit filed by a GlaxoSmithKline unit.

Perrigo has assumed responsibility for the litigation and will immediately begin working on the transfer of production to a Perrigo site with the intention to amend the ANDA accordingly. Shares of KV Pharmaceuticals rose 4 percent to $3.09 in early trade on the New York Stock Exchange. Perrigo shares were up 1 percent at $32.25 on Nasdaq. (Reporting by Vidya L Nathan in Bangalore; Editing by Mike Miller)

Teen Acne and Depression: Can Mood Worsen Skin?

Acne is a diabolically cruel thing: somehow it strikes your most visible feature just at the age when you become most vulnerable to a gaze. Not surprisingly, acne is often accompanied by serious depression among teenagers. In fact, a 1999 study found that kids with acne bad enough to prompt a trip to the dermatologist reported having emotional and social problems as severe as those reported by patients with disabling diabetes and epilepsy.

Other studies have shown similar, if less extreme, reactions to bad cases of acne. And so an international team of researchers — including scientists from Harvard Medical School in Boston and University Medical College in Tibet — decided the acne-depression question needed further investigation. The team's intriguing new paper, published this week in the open-access journal BMC Public Health, not only confirms that acne goes hand in hand with depression and anxiety but further suggests that teens' mental distress may in fact be worsening the condition of their skin.

Led by Jon Halvorsen, a dermatologist at the University of Oslo in Norway, the researchers launched their study in 2004, inviting every 18- and 19-year-old who was finishing high school in Oslo to answer some questions about zits and other things. Of the 3,659 students invited, 90% participated, along with 467 other 18- and 19-year-olds who were not graduating. The teenagers completed questionnaires about the severity of their acne as well as how much anxiety and depression they were experiencing, what they usually ate and whether they smoked and drank. Separately, the researchers collected socioeconomic data on the teens from the country's central information-gathering agency, Statistics Norway.

The results show that the level of mental distress kids reported was strongly associated with how much acne they said they had, independent of other factors like diet or lifestyle. Roughly 19% of all kids who reported symptoms of anxiety and depression said they had acne, compared to only 12% of those who reported no mental distress. Among boys, those with depression and anxiety were 68% more likely to report acne than their happier peers; among girls, those with mental distress were twice as likely as those without to report acne.

The study found, for the first time, a linear relationship between mood and pimples: the worse the mental-illness symptoms, the worse the acne. It's possible that the association simply means that kids who feel depressed are more likely to report they have bad acne, even if they don't — but previous studies have shown that dermatologists independently agree with teens' self-reports of acne severity about 75% of the time. Some of the depressed and anxious kids in the Norwegian study may have exaggerated their acne, but in a sample as large as this one, it's unlikely that most did.

So how could mental-health problems actually exacerbate acne? One theory is that people with mental distress eat more junk food. Dearly held teen lore says that overindulging in chocolate and potato chips — which can make greasy fingers and, consequently, greasy faces — spawns pimples. This is mostly myth, according to the study's findings, although they offered a bit of support for the notion that diet plays a role. Girls in the study who consumed few vegetables tended to have more zits than girls who ate lots of greens. But diet was entirely irrelevant for boys.

The authors also discount other lifestyle factors. The Norwegian adolescents who said they regularly use alcohol and cigarettes were no more likely to report acne than those who were abstemious. Only mental distress was strongly correlated with acne in both boys and girls.

But that still doesn't answer the question of what mechanism might be at work. The authors offer a few hypotheses. For instance, stress may somehow stimulate the growth of nerve fibers near sebaceous glands, which in turn contributes to the increased production of sebum — the fatty substance that combines with cell debris and dead skin cells to form those familiar blackheads and pustules. (All together now: Eww.) That theory is unproved, but previous research on the effects of depression and acne drugs suggests the authors may be onto something: we know, for example, that antidepressants can improve acne. We also know that a widely used drug that treats acne, Accutane (isotretinoin), has been associated with an increase in depression, although no causal link has been established.

The new study has some obvious shortcomings, particularly that it relies entirely on self-reports from a self-selected group of respondents. Much more rigorous research needs to be conducted to understand the relationship between mental illness and pimples — as well as the root cause of bad cases of acne. But in the meantime, drug companies might want to start working on a Clearasil-Prozac miracle cream.

Acne, Pregnancy Among Disqualifying Conditions

A proposal to make preexisting health conditions irrelevant in the sale of insurance policies could help not just the seriously ill but also people who might consider themselves healthy, documents released Friday by a California-based advocacy group illustrate.

Health insurers have issued guidelines saying they could deny coverage to people suffering from such conditions as acne, hemorrhoids and bunions.

One big insurer refused to issue individual policies to police officers and firefighters, along with people in other hazardous occupations.

Some treated pregnancy or the intention to adopt as a reason for rejection.

As Congress and President Obama work on legislation to overhaul the nation's health-care system, one of their main objectives is to stop insurers from denying coverage on the basis of health status. Proposed legislation would prohibit insurers from denying coverage to individuals with preexisting conditions or charging them higher premiums because of their medical history -- practices known as medical underwriting.

Even the insurance lobby has endorsed that goal as part of a larger reform package in which the government would extend coverage to the uninsured, greatly expanding the market for insurance.

Guidelines that insurance companies have written for professionals involved in selling policies offer a glimpse inside the underwriting process.

"What these documents show is the lengths to which insurance companies are willing to go to make a profit," said Jerry Flanagan, health-care policy director of the advocacy group Consumer Watchdog, which distributed the documents Friday. "What it shows is that insurance companies want premiums without any risk."

Consumer Watchdog argues that consumers should be given the option of enrolling in a government-run health plan. It obtained the documents from a California insurance broker, Flanagan said.

A PacifiCare "Medical Underwriting Guidelines" document from 2003 lists under "Ineligible Occupations" such risk-takers as stunt people, test pilots and circus workers -- along with police officers, firefighters and migrant workers.

Uninsurable conditions included pregnancy, and being an "expectant father" was grounds for "automatic rejection." So was having received "therapy/counseling" within six months of the application. There was also this more general disqualifier: "currently experiencing/experienced within the last 12 months symptoms for which a physician has not been consulted."

The PacifiCare document "is completely outdated and predates the acquisition of PacifiCare by United Healthcare," Cheryl J. Randolph, a spokeswoman for the parent company, said by e-mail. She declined to provide current underwriting documents.

"Underwriting enables insurers to adequately assess risks, keeping premium costs lower for more consumers," she added.

Health Net guidelines for 2006 say that people could be denied coverage or charged higher premiums if they were taking certain medications, including Zyrtec, an allergy remedy, and Lamisil, which is widely advertised as a treatment for toenail fungus.

Pregnant women could be rejected, as could expectant fathers, the document said.

A Health Net spokeswoman did not respond to requests to comment.

Blue Cross of California guidelines for 2004 said potential disqualifiers included chronic tonsillitis and, under certain circumstances, varicose veins.

Kristin E. Binns, a spokeswoman for parent company WellPoint, said by e-mail that she could not comment on the guidelines because they are from years ago.