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Transformation Strategy
québec Transformation Strategy
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Aeterna Zentaris president and CEO David Dodd
Anew CEO and president is said to have 100 days to make a real difference in their organization. For David Dodd, stepping into the role of CEO and president of Aeterna Zentaris in April of this year, those fi rst hundred days may have gone by rather quickly, but he is already well on his way to implementing his strategy for the company, going from a sole focus on R&D to becoming a company that is ready to take the next step, commercializing the promising compounds in its pipeline.
One would say it’s because of the maturity of this pipeline that Dodd was sought out to head up the Québec-based company in the fi rst place. While his wealth of experience in the sector made him a leading candidate for the role, it wasn’t just a case of Aeterna Zentaris wanting him. Dodd also wanted to be part of Aeterna Zentaris. In fact, he was so impressed by what he saw in the company and its potential when the courting process started, that prior to assuming the role of president and CEO, he also became a shareholder in the company.
“I wanted to send them a clear message of interest not in just the position but also in the company. My goal was to fi nd a company that I could really sink my teeth into, one that was well positioned, and Aeterna Zentaris was exactly what I was looking for,” he says.
If there’s an individual who knows an opportunity when he sees it, it’s Dodd. A business oriented individual, Dodd’s executive management experience in the pharmaceutical and biotechnology industries spans more than 35 years. He’s worked with small biotech fi rms (Serologicals, BioReliance, Stem Cell Sciences, Geo Vax) mid-sized pharma (Solvay) as well as big pharma (Abbott, BMS and Wyeth). One of his greatest achievements was during his six-year tenure as president, CEO and director of Serologicals Corporation, where he increased the market value of that company from $85 million in June 2000 to the point where it was acquired in an all-cash sale by Millipore Corporation in July 2006 for $1.5 billion.
He believes that Aeterna Zentaris has the pipeline to achieve the same type of success.
“I guess for starters, I really like the idea of a biopharmaceutical company that has products in oncology and endocrinology. These are two very speciality type markets where I believe you’ll fi nd a lot of opportunity if you deliver good products and services,” he says.
It all starts with the company’s lead product: macimorelin acetate (formerly AEZS-130).
Macimorelin acetate is an oral diagnostic for adult growth hormone defi ciency (AGHD), a condition where there is a negative impact to the pituitary gland which causes hormonal imbalance or disruption. The product is an orally-active ghrelin agonist that when ingested it stimulates a GH secretion in a patient, making it easier to diagnose AGHD.
“Typically it’s hard to diagnose AGHD, most current means need to be injected. Ours is the fi rst that can be taken orally; it works faster and has a favorable safety profi le. You simply take the blood from a patient who has taken AEZS-130, and conduct a confi rmatory test on the blood sample to determine whether the patient has AGHD. The product can be used in a confi rmatory manner, and there’s opportunity to expand that very rapidly from a marketing standpoint.”
Even more exciting is the fact that the company is now in the fi nal stages of fi ling a NDA for a commercial licence in the U.S. Moreover, the same product is also being assessed in Phase 2 trials as a therapeutic treatment for severe chronic diseases such as cancer induced cachexia.
Likewise, on the oncology side, the company has a second lead product in its pipeline, zoptarelin doxorubicin (formerly AEZS-108) which is in a Phase 3 program for endometrial cancer. Endometrial cancer develops when cells in the inner lining of the uterus (the endometrium) become abnormal and grow uncontrollably.
“This molecule is part of a targeted cancer treatment; it allows specifi c targeting of tumour cells expressing the LHRH receptor. For example, when you use standard chemotherapy to treat a patient,
you affect healthy cells as well as cancer cells. With AEZS-108 you’re targeting specific characteristics (LHRH receptors) of the cells, and your drug is delivered to those cells only. The target receptor is present on cancer cells but not on non-cancer cells.”
According to Dodd, like AEZS-130, there is no approved product in the U.S. for endometrial cancer, so once again Aeterna Zentaris is aiming to be the first. The company has already dosed its first patient in its Phase 3 trial in this indication.
“We’ve opened 11 sites, four in the U.S., and seven in Israel and now we are ironing out details on our last regulatory and contracting details for the Canadian sites. Moreover we also have other trials in Phase 2 with the same molecule for additional cancers like ovarian, prostate, bladder and triple negative breast cancer,” said Dodd.
In both cases, Dodd believes the company is on the verge of delivering some really nice value in its pipeline. Of course, there’s always an underlying fear due to the uncertainty inherent in this industry that the possibility of failure is always lurking around the corner. This is especially true in Aeterna Zentaris’ case where circumstance has dealt its share of mishaps to the company.
“You can say Aeterna Zentaris has had some bad luck over the years when it comes to Phase 3 trials,” Dodd comments alluding to the company’s recent failure in a Phase 3 study of a product it has since dropped: perifosine. After promising Phase 2 results, the Phase 3 trial was discontinued only a month before he came on board. Prior to that, the company had several other products reach Phase 3 and bow out. For these reasons, one of the first orders of business for Dodd was ensuring that the company would not just focus on internal R&D, but rather look externally for new opportunities.
“This is a topic I’ve spoken much about since joining the company, whether it is looking at opportunities to in-license or to someway obtain already-on-the market products that align with our strengths, be it oncology or endocrinology. It’s important to show not only what we alone can develop, but also to be able to provide a high value differentiated portfolio because at the end of the day that is what builds value in a company.”
Moreover, by adding already on the market products Aeterna Zentaris will be able to create a revenue stream to help finance its portfolio of oncology candidates.
Lastly, part of his strategy is ensuring that the company honours its commitments to strengthen the company’s reputation in the eyes of investors.
“It’s very important to us that when we make commitments we deliver on those and in time. Over the past few months, we have successfully met four out of the five critical objectives set for ourselves when I joined the company including: (1) the transfer of Cetrotide® manufacturing rights to Merck Serono; (2) the initiation of patient recruitment and dosing of the first patient, as well the signed agreement with Ergomed as CRO for our very important Phase 3 ZoptEC trial in endometrial cancer; (3) successfully raising financing in support of our ongoing operations and development programs; and (4) making significant efforts to obtaining on-the-market products that
will accelerate our strategy aimed at transitioning to a revenue and cash generating company. As for the fifth objective, we are finalizing our preparation for submitting the NDA for macimorelin acetate (AEZS 130) as the only approved oral diagnostic test for adult growth hormone deficiency.”
Perhaps most importantly, he believes that the talent as much as the pipeline is Aeterna Zentaris’ greatest asset to sustaining success.
“In any leadership change, the easiest thing is just to change people, but to me that isn’t true leadership. I think leadership is the ability to go into an organization and work with the organization and show them that they can achieve more than they thought they could. I think this is something I do well, helping people realize their potential. And having sat down with every employee, there is a very strong belief among them in what we have developed is strong, sound and capable of really improving people’s lives. Our people have the will to succeed, and I wouldn’t be here if I didn’t believe in them and this company.”
To see this story online visit http://biotechnologyfocus.ca/?p=9070
