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Solstice Looks for Shot in Competitive Botox Market

Solstice Looks for Shot in Competitive Botox Market

Biotech: San Diego Firm Pushing Myobloc as A Reasonable Alternative

BY MARION WEBB

By early 2005, San Diego-based Solstice Neurosciences Inc.’s sales force will be calling on thousands of neurologists in the country, hoping to revive interest in Myobloc, a neurotoxin similar to Botox, a widely used wrinkle-filler.

Industry experts predict, however, the small specialty pharmaceutical firm faces an uphill battle in trying to carve out a piece of Irvine-based Botox-maker Allergan Inc.’s share as market leader.

The botulinum toxin type A (Botox) has long been the doctors’ choice in treating such disabling neurological disorders as chronic muscle spasms in the neck and head, as well as for cosmetic uses such as temporarily smoothing out wrinkles.

If John Bruens, Solstice’s president and chief executive, and Arthur Morelli, the company’s executive vice president, have their way, Myobloc will enjoy a revival.

The two former managers of Irish drug maker Elan Corp. started Solstice in September by acquiring the worldwide rights, intellectual property, product inventory, and the manufacturing plant for Myobloc from their former company, which ran out of funds to develop and market Myobloc.

It was of one several businesses Elan shed when it was accused of questionable accounting practices in 2002.

But Bruens and Morelli saw Myobloc as a viable alternative to Botox.

‘High Level Of Confidence’

“I think after spending a year on re-establishing a new commercial strategy, we have had a high level of confidence to build a business around it (Myobloc),” said Bruens.

He managed Elan’s Myobloc business for two years until December, while Morelli headed the marketing of it through that year.

This month, the two men also won the backing of several venture capital firms, raising $40 million.

Thomas McNerney & Partners, Investor Growth Capital, and Morgan Stanley, all located in New York City, joined Oxford Bioscience Partners of Boston in participating in the financing round.

Asked about funding Solstice, Mark Carthy, a general partner with Oxford Bioscience, said the company found that “Botox has created an exciting market and there is opportunity for a competitor in that market.”

Bruens put the botulinum toxin business at $600 million globally , $350 million for therapeutics and $250 million for cosmetics , with Botox way ahead of the pack.

This year, Allergan reported Botox sales of $150.7 million for the first quarter alone.

That compares with U.S. peak sales of $18.4 million for Myobloc for 2002, its second year on the market, Solstice said.

Botox Sales Still Growing

While Botox has won Food and Drug Administration approval for three therapeutic indications , cervical dystonia, or severe cramping in the muscles of neck and head; blepharospasm, or involuntary eyelid twitching; and strabismus, crossed eyes , Myobloc is approved only for cervical dystonia.

Allergan expects Botox sales to grow 25 percent this year as it seeks approval for treating excessive sweating and studies it for treating migraines.

Dr. Geoffrey Sheean, a neurologist at UC San Diego’s Thornton Hospital in La Jolla, said he finds both Myobloc and Botox highly effective for treating neurological disorders.

But, like most doctors, he prefers Botox.

Sheean said he anticipates Solstice will have a tough time trying to persuade doctors to trade Botox for Myobloc for several reasons.

“The main reason is that most doctors who are injecting Botox are used to injecting Botox,” he said. “It’s been long-established in the U.S., so in order to start using Myobloc you have to switch altogether.”

A big problem for doctors is Myobloc’s dosage, he found. Botox comes in a 100-unit bottle vs. Myobloc’s 5,000-unit bottle.

“It’s a little awkward, because there is no fixed conversion factor and you have to be cautious to change from one type to another,” Sheean said.

Most physicians don’t bother.

A Better Alternative?

He also pointed to anecdotal information from patients complaining that Myobloc causes more pain during injection and causes dryness of the mouth.

In patients with Parkinson’s disease who suffer from excessive salivation, Myobloc’s one side effect is beneficial. For that reason Sheean prefers injecting Myobloc in Parkinson’s patients.

However, he disagreed with Bruens that Myobloc’s newer formula makes it a better option for patients.

Botox has been on the market since 1989, but it’s not an old drug. It was only in 1997 that Allergan introduced an improved and purer form of Botox. That, combined with 15 years of experience by doctors using Botox, has led to a drastic decline in the prevalence of drug resistance in Botox patients, Sheean said.

Today, less than 5 percent of patients who are repeatedly injected with Botox resist the drug. He agreed that Myobloc’s ready-to-use formulation makes it easier to give to patients than Botox, a freeze-dried powder that needs water added.

But that still doesn’t make up for the conversion problem, Sheean said.

Bruens wouldn’t comment on marketing strategies for Myobloc, aside from using the typical buzzwords as “better and easier to use.”

He’s already planning for wider use. Besides the required FDA follow-up studies to make sure Myobloc’s effects are long-lasting, Bruens plans to pursue other indications.

Until then, Solstice will spend $10 million to test 150 patients with cervical dystonia until 2008.

The protocol calls for patients to be injected every 12 weeks for up to two years, and then be monitored for an additional two years.

Sheean said while cervical dystonia is a relatively rare disease, and quite random, it can be extremely debilitating and painful.

Lifelong injections with botulinum toxins is a standard treatment for dystonias and is highly effective. It allows patients to go about their daily activities, he said.

Myobloc and Botox both work.

“And there is no reason to think that Myobloc cannot be as effective as Botox,” Sheean said. But, he added, “The greatest obstacle that the company will have is overcoming the tremendous market share Botox already has.”

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