- We are executing on our "focus, fix and grow" strategic plan, and are halfway thru the timeframe for this plan
- Recent achievement was Watson license for Anturol in US and canada, WPI assumes manufacturing and scale-up expenses, AIS will receive milestone and escalating royalties
- Watson see this as excellent opportunity to grow their branded franchise. They are a successful player in the large OAB market. PDUFA date is 12/8/11. Watson has a well established commercial infrastructure and a growing presence in urology and ob-gyn fields.
- We recently announced the successful clinical trial of Vibex MTX, which completed enrollment ahead of schedule. The results showed bioequivalence vs IM or SC needle and syringe. Trial met its endpoint, plus had positive patient feedback. Expect NDA filing in 2012 and EU filing shortly thereafter (expect to pursue a pharma partner for Europe). We have filed additional patent applications based on data from this trial.
- $2.2m product revenue 2q2011 up from $1.2m 2q2010, driven by HGH
- $33.3m cash 6/30/11, plenty of runway and flexibility to invest in products and opportunities
- Development revenue for other Teva programs continues to grow, a reflection of solid progress
- ANDA for generic epipen under review, as well as ligitation
- 2nd autoinjector ANDA under active review. Currently completing commercial tooling for this redesigned product. Then will conduct small user study to submit to FDA. could launch in 2012.
- pen injector programs: additional statement of work signed with Teva (the basis for increased revenues). We continue to complete development of devices to then conduct user studies to form basis for FDA filings. The first pen is likely to be an ANDA, 2nd will be branded product.
- $3.5m revenue 2q11 vs $3.2m 2q10. Product sales $2.2m vs $1.2 up 93%
- $7.1m rev 1h11 from $6.4 1h10
- 2q11 $0.5m royalties from $0.4m 2q10
- Operating expenses up slightly to $7.3m 1h11, R&D $3.7 1h11 down from $4.3m 1h10 (primarily vibex MTX and anturol manuf scale-up in anticipation of approval)
- net loss 2 cents per share in 2q2011, and 3 cents for 1h11
- We are conducting preliminary market research on other potential injectable product candidates
- At least 2 product launches on track for next 2 years
1) oppenheimer: what doses in Methotrexate (MTX) PK study and which doses commercially MTX is usually used at 10-25 mg, our trial had 4 dose levels in that range as part of study. We will meet w/ the FDA this fall to agree on path forward towards NDA filing - ie, what type of user studies needed in RA pts. We are working from guidelines received a couple years ago from FDA when we initiated this program.
Anturol pricing vs Gelnique? [laughs] "great question". The pricing decision is Watson's, but Anturol will be positioned as a premium brand. We are incredibly impressed with their knowledge in the segment, if we get a premium that would be fantastic. OAB space is very competitive, all branded products are about $150 per month, expect Anturol to be in that range. We will receive a fairly healthy milestone payment on approval
2) more detail on marketing plans for Anturol? The timing of launch would be 2q2012 (stock, introduce, get on formulary)...but we will hope for 1q2012, possibly tied to urology meeting). This will be Watson's primary product in OAB space...they will focus exclusively on Anturol [This is significant, as Watson currently sells the other gel and patch on the market, Gelnique and Oxytrol]. They have about 200 reps, will put tremendous focus on the launch, they see this as a way to expand their presence in the market over time.
MTX - What else is necessary besides completed PK study? We completed the clinical PK study w/ 4 doses (0.5-1 sec injection vs intramuscular or sub-cutaneous needle and syringe. The performance in these rheumatoid arthritis (RA) patients was very good, patients found device really easy to use and nearly pain free. We don't have to look at ACR scores, only performance of drug in body. Next stage is user/usability studies (need to agree on what FDA needs to see, maybe incorporate minor changes to device)...these usually only take a couple months... "we really know how to get these products across the goal line" from experience in other programs. manufactuing? Our contract manufacturer in Canada made the drug batches for trials. The product is stable in in the vibex system.
Teva 2nd product - still possible 2011 approval? New study was part of original comments from FDA re new device (always required), Studies are simple, believe we can file this year, then depends on review time, so looking at 2012 approval. [Matches my prediction of delay]
EpiPen update? Pleminiary hearing sept 2011, then judge renders what next step is. Final hearing February 2012, depositions ongoing
3) Roth capital: Clueless question on libigel...efficacy data expected fall 2011, safety data in 2012 and will file NDA in 2012.
AIS has international rights...who is negotiating partnerships? Any deal will take place after efficacy data is issued [again this has been my belief all along, BPAX has never come out and said it though]. From our perspective, we would like to see global partnership put in place and that is where our expectations are, we have communicated this to BioSante.
Methotrexate - will this be sold as branded product at premium price? Yes. Differentiation? MTX is used alone before biologics, then in combo with biologics for RA. Oral methotrexate is not absorbed well at higher doses than 15 mg. There is no sub-cutaneous version on US market. Our product would allow higher doses, potential better therapeutic responses, potential to leave patients on MTX longer before switching to more expensive biologics.
Potential new product? We have another injector product where we have completed market research w/ physicians. Still need to complete technical feasibility studies, this program would be a new generation of Vibex devices, will announce later in 2011.
Is the $1.9m per quarter R&D spend in 2q2011 a good baseline? Yes, and could go down a bit