Developing Innovative Therapeutics In Fields Of Oncology And Infectious Disease

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By Tonya Costoff

Is What Keeps This Executive Focused

Heading up a biopharmaceutical company is no easy task, it's full of challenges, risks and plenty of bumps along the way, but Hans J. Mäder, president and CEO of Ambrilia Biopharma Inc., wouldn't have it any other way.

Ambrilia Biopharma Inc. is all about developing innovative, safe and effective therapies that address unmet medical needs in the fields of oncology and infectious diseases. Ambrilia's product portfolio includes an anti-cancer therapeutic peptide (PCK3145), a Tumor Vasculature Targeting (TVT) technology platform, an improved, prolonged release formulation of Octreotide, a new formulation of Goserelin, promising anti-HIV treatments (PPL-100 and an Integrase Inhibitor Program) as well as other anti-virals and immunomodulators.

Ambrilia's strategy is to discover or acquire and advance drug candidates through early to mid-stage clinical trials and then pursue co-development or out-licensing options with pharmaceutical companies. At the same time, Ambrilia is developing and manufacturing improved formulations of existing drugs in order to provide the Company with an early and sustainable cash flow.

Ambrilia Biopharma was created pursuant to the merger via acquisition of Procyon Biopharma, a publicly-traded Montreal-based biotechnology company that was developping innovative therapeutics in the fields of oncology and HIV/AIDS, with Cellpep S.A., a French private biotechnology company that was developing therapeutics in oncology and infectious diseases. The merger, along with a concomitant $18.1 million financing was completed in March 2006.

Exclusive worldwide rights to PPL-100 and its related compounds have been granted to Merck & Co., Inc. in return for a $US 17 million upfront payment, potential milestones that could reach $212 million and royalties. "We know Merck is quite active, but so are other ones, this was actually a competitive bid. Merck just wanted it more than others," said Mäder of the deal.

Ambrilia's PPL-100 is a protease inhibitor (PI), which binds specifically to HIV-1 protease, the enzyme that allows the virus to finalize its maturation, and therefore results in the formation of immature and non-infectious viral particles. Contrary to most commercially available Protease Inhibitors that cause serious side effects, PPL-100 was shown to be well tolerated and non-toxic. More importantly a recent study demonstrated that PPL-100 has a high genetic barrier, therefore making it more difficult for the HIV virus to develop resistant strains. Single-dose and repeat dose study data suggests that PPL-100 is a potential first-line, once or twice daily, without ritonavir boosting PI to treat a large spectrum of HIV/AIDS patients.

Mäder came onboard when Ambrilia was still known as Procyon Biopharma Inc. When Mäder joined Procyon, it was a company that didn't have much money at the time and needed to raise some. He saw it as a challenge and was happy to take it on.
"I like challenges and they (Procyon at the time) did have multi products. I always liked to manage risks, that's what I learned in the pharmaceutical industry and that's what I continue to learn in biotech," said Mäder.

"I try to reduce the risk as much as I can for yourself and investors. You know in product development there's not much you can do; it takes so many years and so much money and so much know-how and science to get all these clinical trials done. You can't really cut corners. You cut corners and you increase the risk. So the only way to try to manage risk in this area is to have a portfolio in a company that has several products in different stages of development. All biotech seems to be suffering from the same disease and that's shortness of cash. Everyone in biotech needs cash. So if you can try to manage that by creating a mix, like Ambrilia has, I think that's a good thing for the investors," explained Mäder.

Mäder himself comes from a varied background with extensive experience in the pharmaceutical industry in Canada, the U.S. and Europe, where he occupied a number of senior executive management positions. In 1999 he joined Procyon as president and CEO. During his tenure with the company, he conducted the company's TSX listing and raised over $92 million including first-time investments from major Quebec-based venture capital firms. As far as business development goes, he negotiated three out-licensing deals with important pharmaceutical partners. Mäder's educational background includes the equivalent of a Bachelor's Degree in Chemistry from the Swiss Technical Institute in Basel, Switzerland.

With so many biopharmaceutical companies out there, one can ask, what makes Ambrilia stand apart? How has it managed to have such success? Mäder believes he has the answer to the question.
"Our model is different. First of all we are not a one product model company, we have several products in different stages of development," said Mäder. "Because it's all about managing the risk, biotech is very high risk. If you hit the jackpot, it's like the lottery, the return is huge but the risk is high. So what you try to do is manage the risk by having a portfolio of products, which are in different stages of development."
Mäder goes on to explain that by having products in different stages of development, it allows the company to be on the market, pumping in revenues to further help reduce the risk for investors, while helping it to fund some of the other products that take longer to develop. For innovators searching for their own formula for success, Mäder has a couple of words of advice.

"Access to cash is key, so make sure you have access to cash and have the right investors. In biotech they are a different breed. Make sure you have people that understand biotech well. Make sure you have investors that have patience and are willing to keep their investment there for years and not bother you every two to three months because you have no news," said Mäder.

Another key that Mäder stresses is for a company to remain private as long as possible. "If you can stay private, stay private as long as you can. Try to grow your company to a strength that you can manage your investors without being public. Being public is not an easy thing, especially up in Canada where you don't have this much of a big investment space. Ideally to me today, US listing as quickly as possible if you go public."

With so many start-up companies out there, it's easy to get lost in the hype and have the company go off the rails. Where this can often happen, in Mäder's opinion, is with the timeline a company initially starts out with.

"People think things can go quickly. Timelines are usually longer than you think cause things never go the way you think. So something I've learned is try to under-promise. That's easily said though. If you're a private company it's easier to under-promise, especially when you have competent investors who understand the business. If you have a public company it's more difficult to under-promise because the everyday investor there wants news almost every week," explained Mäder.
Another problem Mäder sees with the industry is the amount of start-ups out there, stating that he believes there are far too many.

"We have companies out there trying to fight for their life and access to cash, which there is little of in Canada," said Mäder. So what's his solution to the problem? Consolidation. "What needs to be done is consolidate. You need to have consolidators to raise cash, to increase the value of the company and try to manage the risk. Don't be afraid to consolidate cause as I said, there are too many small companies out there who won't make it."
What he finds unfortunate about the state of biotechnology today is that Canada has such excellent research, universities and scientists and the fact that research can be done in Canada very inexpensively, yet more and more contracts/business is being lost to the U.S. So how can this be changed?

"It takes vision. It takes vision from the government to help potential investors and it takes vision from investors as well. If you look at it, the real biotech money and cash and real entrepreneurship is down in the U.S.," said Mäder. "Having a scientific know-how is not enough. You've got to have some business savvy to go into this business and you have to enjoy it and like, you have to have fun with it."