Auxilium Pharmaceuticals Inc. (AUXL)

[pennybuffet]

Looks like a possible short squeeze in the near future. The trigger appears to be around $30. If it can break that the covering may begin. Possible flip here. Keep it on watch. Huge short interest and significant increase in call options signaling a possible run.

[surf1944]

7:11AM Auxilium Pharma misses by $0.03, reports revs in-line (AUXL) 24.24 : Reports Q2 (Jun) loss of $0.28 per share, $0.03 worse than the Thomson Reuters consensus of ($0.25); revenues rose 28.8% year/year to $50.5 mln vs the $50.9 mln consensus. "The leading indicators that we use to track the launch of XIAFLEX continue to move as expected and we are encouraged by the increasing positive feedback received from patients, physicians and payers on its efficacy and safety... Testim performed well again with a 25.9% U.S. net revenue growth year over year in the second quarter." For the third quarter 2010, Auxilium anticipates that XIAFLEX net revenues will be in the range of $5.5 million to $6.5 million, including approximately $1.1 million in revenue recognized from milestones previously received under the Pfizer contract.

[surf1944]

Auxilium Pharma AUXL Oppenheimer Outperform » Perform

[surf1944]

Auxilium Pharmaceuticals to Present at the Goldman Sachs Global Healthcare Conference

http://finance.yahoo.com/news/Auxilium-Pharmaceuticals-to-iw-696557494.html?x=0&.v=1

[surf1944]

Auxilium Pharma AUXL Caris & Company Sell » Average $36

[surf1944]

Auxilium rises as analyst review Xiaflex launch
Analysts say launch of new Auxilium drug is going well and should meet Street estimates

On Monday April 5, 2010, 1:43 pm EDT
NEW YORK (AP) -- Shares of Auxilium Pharmaceuticals Inc. climbed Monday after analysts said physicians are showing strong interest in the company's drug Xiaflex.

Analysts for Jefferies & Co. and Collins Stewart both said about 550 physicians have received instructional materials for Xiaflex, which suggests they plan to use the drug on patients. Both saw that as a promising sign for sales and kept "Buy" ratings on the stock.

In afternoon trading, Auxilium shares rose $2.86, or 9.3 percent, to $33.49 in afternoon trading. The stock has ranged from $21.85 to $37.28 over the past year.

Xiaflex is intended to treat Dupuytren's contracture, a condition in which the tendons of the hand thicken and shorten, causing the fingers to curve inward. It reached the market in March.

Salveen Kochnover of Collins Stewart said the instructional program for Xiaflex includes a video or manual about drug, including how to administer it. After a physician receives those materials, the company gives a guide covering key details, side effects, storage, and details on purchase and scheduling of treatment.

Jefferies analyst Thomas Wei said many more hand surgeons could enroll in the training program over the coming months, making it more likely Xiaflex revenue will meet his expectations or surpass them. Wei estimated $42.7 million in Xiaflex sales this year, and said Wall Street is looking for $39.5 million on average.

Kochnover expects $42.5 million in revenue. In a note to clients, she wrote that physicians are building up knowledge by using Xiaflex on patients with moderate Dupuytren's who don't have other conditions. She added that Auxilium is handling concerns that government reimbursement rates for Xiaflex treatment are too low. Kochnover still expects reimbursement concerns to hurt sales later this year, however.

[surf1944]

7:05AM Auxilium Pharma beats by $0.06, beats on revs (AUXL) 31.70 : Reports Q4 (Dec) loss of $0.25 per share, $0.06 better than the First Call consensus of ($0.31); revenues rose 37.9% year/year to $48 mln vs the $44.3 mln consensus. Sales of Testim in the U.S. were $42.3 million, a 24.4% increase over the $34.0 million recognized in the fourth quarter of 2008. "We believe 2009 was a great success for Auxilium. We achieved record revenues for Testim in 2009, advanced XIAFLEX through U.S. regulatory review followed by approval in early 2010 for Dupuytren's contracture and released encouraging XIAFLEX Phase IIb clinical data in Peyronie's disease... With the recent approval of XIAFLEX for adult Dupuytren's contracture patients with a palpable cord, we believe that XIAFLEX represents a blockbuster opportunity that can provide sustainable long-term growth for the Company."

[surf1944]

7:01AM Auxilium Pharma announcesFDA approval for XIAFLEX for the treatment of Dupuytren's Contracture (AUXL) 28.08 : Co announced that it has received marketing approval from the U.S. Food and Drug Administration (FDA) for XIAFLEX, a novel, first-in-class, orphan-designated, biologic, for the treatment of adult Dupuytren's contracture patients with a palpable cord. The Company expects to begin shipping XIAFLEX to its distribution partners in early March in advance of a launch planned for late March.

[surf1944]

6:15PM Auxilium Pharma: FDA approves Xiaflex for debilitating hand condition (AUXL) 28.08 +0.05 : Co announced the The U.S. Food and Drug Administration approved Xiaflex (collagenase clostridium histolyticum) as the first drug to treat a progressive hand disease known as Dupuytren's contracture, which can affect a person's ability to straighten and properly use their fingers.

[surf1944]

7:01AM Auxilium Pharma and Pfizer announce Commencement of European Regulatory Review of XIAFLEXTM for the Treatment of Dupuytren's Contractur (AUXL) 29.06 : Pfizer (PFE) and Auxilium Pharmaceuticals (AUXL) announce that Pfizer received notification from the European Medicines Agency that the Marketing Authorization Application for XIAFLEX (collagenase clostridium histolyticum), a novel, first-in-class, biologic for the treatment of Dupuytren's contracture (a condition resulting in the contracture of the fingers into the palm), has completed the validation phase successfully. As a result, the scientific/technical review procedure commenced on 21 January 2010. Based on the completion of the validation phase and today's confirmation from the European Medicines Agency of the start of the regulatory review procedure, Auxilium will receive a $15 million milestone payment from Pfizer.

[surf1944]

Auxilium Pharma AUXL Jefferies & Co started with a Buy $42

[gfp927z]

Starting to move, but I'm no longer that confident about this one.

Having an enzyme circulating through the bloodstream that breaks down collagen / connective tissue certainly could raise some red flags. Will be interesting to see how the FDA panel vote goes.

[gfp927z]

An earlier Pharmawire article on Auxilium -


>>> by Elizabeth Krutoholow and Jacqueline Kwong

09:27 Auxilium’s Xiaflex Advisory Panel to focus on surgeon education program to limit tendon rupture, nerve damage, surgeons say

Story Auxilium’s (NASDAQ:AUXL) Xiaflex FDA Advisory Panel will likely be focused on a surgeon education and training program that will be in place to limit side effects from improper use, such as tendon rupture and digital nerve damage, hand surgeons said.

The FDA’s Arthritis Advisory Committee will tentatively review Xiaflex on 16 September 2009. The FDA advisory committee is looking at including hand and/or orthopedic surgeons on the panel, but the breakdown has not been revealed, according to Will Sargent, vice president of investor relations and corporate communications at Auxilium.

Regardless of the FDA pathway, Auxilium believes that educating the surgeon base about the proper technique for injecting Xiaflex is important, Sargent said. The company is planning a “robust” education program that it plans to share with the FDA, and is in a dialogue now, he said. The education program would ensure that surgeons are aware of the risk/benefit profile and are aware of what worked best in clinical testing, he added.

Dr Srinath Kamineni, a consultant orthopedic surgeon and elbow, shoulder, hand and wrist specialist in London, said that extensive training is needed - citing the potential risks of tendon rupture and nerve damage with injections. Tendon rupture is a huge concern because if Xiaflex is injected in the wrong place, it could lead to tendon breakdown, he said.

In the CORD I and II studies, the open-label JOINT I and II studies and the pharmacokinetics study, there were a total of three confirmed tendon ruptures (rate per injection = 0.14%); one reported tendon rupture remains unconfirmed (rate per injection = 0.05%).

The rate of tendon rupture is probably acceptable, according to Dr Roy Kulick, associate professor of orthopedic surgery at Albert Einstein School of Medicine and director of orthopedic hand surgery at Montefiore Medical Center in New York. If the cord is on top of a tendon, ruptures could occur if the injections are deep but they do not happen often, he said.

Tendon rupture is a major concern, said Dr Robert Szabo, professor of orthopedic and plastic surgery at the UC Davis School of Medicine. The clinical trials have been performed by surgeons who are more familiar with the disease so the results are better than they will be once Xiaflex is available to the public. The concern is that Xiaflex will have to be limited to surgeons, he said. If it is marketed to everyone, there will be a lot of problems, he added.

It is really a question of training, said Dr Larry Hurst, chief of hand surgery and chair of the department of orthopedics of the Health Science Center at the State University of New York at Stony Brook, and primary investigator of the CORD trials, noting that certain trials in Australia were done by rheumatologists.

The rate of tendon rupture was reasonable, said Dr Roy Meals, a clinical professor of orthopedic surgery at the University of California, Los Angeles, and an investigator for Xiaflex. Tendon rupture is partly technique dependent, he said. Education will probably start in hand surgery, where surgeons will be taught the potential risks and benefits of Xiaflex so they can use it safely, he said.

Xiaflex should be approved but with some reservation about widespread use, noted Dr William Townley, a plastic surgeon at Salsbury District Hospital in the UK. The agent will probably have the best safety if given by qualified hand/plastic surgeons with the appropriate anatomical knowledge, experience and ability to deal with complications, as well as awareness of surgical alternatives, he said.

The technique should be relatively easy to pick up, but the company will need to tell doctors to learn it well or else might Xiaflex may cause tendon rupture, said Dr F. Thomas Kaplan, a surgeon at the Indiana Hand Center.

Meals said many physicians hope that Auxilium will restrict the distribution of Xiaflex to prevent rheumatologists and dermatologists from using it because there would probably be more tendon ruptures if they did. These specialties have not seen the cord of tissue that causes the contracture and do not have a good spatial understanding of the hand, he said. “It is a scary thought,” he added.

However, the severity of the rupture depends on which tendon is affected since some patients would not even know that a tendon ruptured if it did not disrupt motion, Meals said, noting that these patients already have limited motion from the contracture and that if Xiaflex brings the contracture towards normal a tendon rupture is much less of a consequence.

Yet a surgeon who spoke on the condition of anonymity said that since some authors are reporting tendon ruptures, he believed that “the nails are in its coffin.” Fasciectomy or fasciotomy seem much safer, he added. The surgeon was not aware of any cases of neurolysis, but said that the occurrence is feasible.

Dr Bing Siang Gan, a surgeon at the Hand and Upper Limb Centre at the University of Western Ontario, agreed that any tendon rupture is one too many.

With nerve damage, the risk becomes higher as one injects distally, similar to traditional surgery, Kamineni explained. In over 1000 patients and over 700 injections, there was no nerve damage, Hurst said. Kaplan also described nerve injury as surprisingly low and added that no one reported temporary numbness.

However, in Dupuytren's, nothing is standard and predictable and while the cord can be palpated, it is not possible to feel the nerves so a physician would know where to inject but would not know where not to inject, Szabo cautioned.

There are different forms of collagen and some are resistant to collagenase, Meals said when asked about the potential for neurolysis. Some patients have experienced skin lacerations with Xiaflex, he noted.

One plastic surgeon noted that improper injection could result in serious consequences. If improperly injected into a digital artery, patients can lose a finger since Xiaflex works through dissolution, he said. He also noted that accidents may result in skin loss.

Vessel rupture is also a concern since many vessels are covered in collagen, said Kamineni, who explained that this could result in hematomas. There is a potential complication of hitting normal tissue with Xiaflex that is depends on on how and how often it is given, said Dr Scott Zashin, a rheumatologist and clinical associate professor of medicine at the University of Texas, Southwestern Medical School.

According to Sargent, while nerve damage appeared to be an issue in vitro, Xiaflex does not appear to affect the nerve, large arteries, or veins.

Kamineni said that lack of proper training is the “quickest way to go wrong” for the company but believed that Xiaflex genuinely has a place in treating Dupuytren's contracture.

Physicians are optimistic about approval, but there is a concern that problems may emerge if patients who do not need Xiaflex get treated with it due to the convenience of administration, Szabo said.

Meals agreed that hand surgeons were enthusiastic over the potential for Xiaflex, but noted that many adverse effects are often identified after an agent comes to market. However, he said that Xiaflex seems remarkably safe.

Auxilium has a market cap of USD 1.33bn. <<<

[gfp927z]

Pharmawire article, reposted from the Biotech Values thread -


>>> 12:56 Auxilium: Xiaflex's presence in the blood system could lead to systemic toxicities; immunogenicity concerns remain - experts
Story * FDA advisory panel meeting scheduled for 16 September 2009

* Detecting Xiaflex in the urine indicates that it traveled through the blood system and could affect other organs

* Xiaflex specific for Types I and III collagen, but liver and lungs abundant with these types of collagen

* Even a slight elevation in IgE levels could elicit severe allergic reaction, said an expert



--------------------------------------------------------------------------------


Auxilium’s (NASDAQ:AUXL) Xiaflex for Dupuytren’s contracture could potentially harm organs in the body, since 7-28% of the collagenase was found in patients’ urine - indicating that the drug enters the blood system, physicians said. The experts interviewed also questioned whether the immune response observed in early clinical trials is negligible.

In a paper titled "Collagen as a Clinical Target: Nonoperative Treatment of Dupuytren’s Disease," which published the data from one of Xiaflex’s Phase II trials, the authors stated that 7-28% of the drug was recovered in patients' urine after 30 to 60 minutes, and claimed that this finding may indicate the kidney’s ability to concentrate collagenase. The paper - which was published in the Journal of Hand Surgery in 2002 - further noted that no collagenase was detected in any of the serum samples collected from one minute to 19.5 hours after the injection was given.

Will Sargent, Auxilium’s vice president of investor relations and corporate communications, also noted that the signal for IgE (immunoglobulin E) – an antibody that plays an important role in allergy – was initially seen in the early development stages of Xiaflex. However, the Phase III results reported that no systemic allergic reactions were noted, despite the fact that the most common adverse events were pain, swelling, bruising and pruritis at the injection site and transient lymph node swelling.

A BLA was recently submitted for Xiaflex and an FDA advisory committee meeting will be held on 16 September 2009.

If 7-28% of collagenase is found in the urine, it means the enzyme must have circulated in the blood plasma and subsequently filtered in the kidney and in the urine, said Dr Erik Ilso Christensen, a professor of anatomy at Aarhus University. Consequently, the collagenase could enter a variety of organs from the blood, notably the liver, he added.

Various PKA studies were done to monitor for systemic exposure but it was very difficult to find evidence, according to Dr Larry Hurst, chief of hand surgery and chair of the department of orthopedics of the Health Science Center at the State University of New York at Stony Brook, and primary investigator of the Phase III CORD trials. The drug "seems to go away," he said.

“How the collagenase got from the Dupuytren’s cord in the hand all the way to the kidney is a mystery if it did not pass through the blood compartment,” said Robert G. Hamilton, PhD, a professor of medicine and pathology at the Johns Hopkins University School of Medicine and the investigator who conducted the pharmacokinetic studies for Xiaflex.

Dr Vijay Vanguri, an instructor in the department of pathology at the University of Massachusetts Medical School, agreed that if collagenase is injected locally into the body, but is detected in the urine, the only way for the drug to appear in the urine is to travel through the bloodstream and filter through the kidneys.

Furthermore, Vanguri noted that the fact the collagenase is circulating through the bloodstream opens the possibility that the drug could affect other organs as well. Collagenase has to be in the blood for some time in order to reach the kidney, added Dr Helmut Rennke, a professor of pathology at Brigham and Women’s Hospital. The time it takes collagenase to travel from the hand to the kidneys provides ample time for the drug to reach other organs in the body, added Rennke.

Sargent noted that Xiaflex is specific for Types I and III collagen, which is not present in nerve bundles. However, Rennke noted that other Types I and III collagen were abundant in other parts of the body.

The liver and lungs could be significantly affected by the type of collagenase that makes up Xiaflex, as both these organs have Types I and III collagen, said Rennke. He also noted that bones have Type I collagen, which could also be "damaged" by the drug.

The company should really test the collagen content in the body, especially in the liver and lungs, to determine whether Xiaflex dramatically decreases the amount of collagen in these organs, Rennke said. A major decrease in collagen content could destruct the structure of these organs, he added.

A couple of sources also questioned whether the lack of collagenase in the tested blood actually indicated that the drug did not circulate through the body. “I suggest that the best analytical assays we had available to measure collagenase were most likely too insensitive to detect the administered level of collagenase that was diluted by the total blood volume of five liters,” said Hamilton. He added that it was possible that the time when the blood was collected was not ideal to catch the bolus of collagenase in the blood.

If the level of collagenase found in the blood is low, but is found in the urine, this indicates that tissues must have absorbed the drug as it flowed through the blood system, added Rennke. “To me, this is evidence that organs take up the collagenase,” he said.

Physicians also questioned whether the immunogenicity response seen in the clinical trials could be considered a negligible response. “Truth be told, even though Xiaflex is injected into the cord in the hand, there is sufficient inflammation at the site to allow effective antibody responses to be detected,” said Hamilton.

He also mentioned that although Auxilium stated that low levels of IgE were detected among patients, the conclusion that there would be no allergic response could not be drawn. As an example, Hamilton noted that very low levels of IgE anti-venom in combination with a honeybee sting could elicit a severe allergic reaction in a predisposed individual.

Because the collagenase used for Xiaflex comes from a bacterial source, there will always be a concern that patients would form an immune complex, said Rennke. A serious immune response, such as serum sickness, could cause serious complications, he added.

Serum sickness is an allergic reaction to proteins derived from a foreign source, such as an animal. A patient with serum sickness will experience hypocomplementemia, which is the condition where proteins cease to function or perform poorly.

Dr Bo Yu, a former researcher at Advance Biofactures, a subsidiary of Biospecifics Therapeutics (NASDAQ:BSTC) - the innovators of collagenase for Dupuytren's contracture – who is familiar with the pharmacokinetic studies of Xiaflex, also agreed that immunogenicity is a potential problem with collagenase.

Rennke further noted that the fact that Xiaflex is given intermittently could greatly decrease the drug's efficacy. The amount of time in between each injection allows patients to form antibodies against the drug, which would make them immune to the collagenase, he said.

Dr Roy Meals, a clinical professor of orthopedic surgery at the University of California, Los Angeles and an investigator for Xiaflex, noted that Xiaflex is a foreign protein so patients can develop an allergic reaction, but such reactions have not been observed. Some patients in the Phase II and III trials had as many as eight injections over a year, and there were no allergic responses. The expression of antibodies was not an issue, he added.

Dr F. Thomas Kaplan, a surgeon at the Indiana Hand Center, noted that blood work was performed throughout the trial for immunogenicity testing, but the results were not provided to the investigators. Investigators were initially concerned about the immunogenicity of Xiaflex because it is a large protein, but the immune response has been studied and it is not an issue, according to Hurst, who has personally done over 300 injections and only seen one episode of hives that was treated with a shot of Benadryl. Lymph node swelling decreased rapidly, he said.

When asked if an immune response would be mechanistically linked to collagenase or if it were specific to Xiaflex itself, Dr Roy Kulick, associate professor of orthopedic surgery at Albert Einstein School of Medicine and director of orthopedic hand surgery at Montefiore Medical Center in New York, noted that mast cells are not activated by collagen breakdown. Mast cells are involved in allergic and anaphylactic response.

With regards to the upcoming advisory panel, the FDA has only requested total antibody data, according to Sargent. He also noted that Savient Pharmaceutical's (NASDAQ:SVNT) advisory panel for its gout drug Krystexxa demonstrates the fact that the FDA Arthritis Advisory Committee does not focus on IgE and only looks for clinical events.

Xiaflex treats Dupuytren’s Contracture – a condition where the hand is constantly in a contracted position - by dissolving the collagen in the contracted cord in the hand. The collagenase that makes up Xiaflex is purified from the bacteria clostridia.

Auxilium has a market cap of USD 1.25bn.

by Jacqueline Kwong and Elizabeth Krutoholow

Source Pharmawire <<<

[gfp927z]

Leerink Swann - Part 3 -


>>> RISKS TO VALUATION

Risks include the potential for disappointing clinical data, regulatory setbacks, and commercial
shortfalls. We are encouraged that Xiaflex clinical data has been presented in detail at major
medical meetings, without any negative surprises. We expect additional publication in a
peer-reviewed medical journal and one-year safety data from the open label extension study to
offer further de-risking in 2009. On the regulatory front, we believe that the FDA and EMEA will
view the risk/reward as favorable given the strong efficacy and relatively benign safety profile
demonstrated to date. Commercial risks seem to be mitigated by a significant amount of pent-up
demand for alternative therapy to surgery. <<<

[gfp927z]

Leerink Swann - Part 2 -


>>> INVESTMENT THESIS

We rate AUXL shares Outperform with a valuation of $35 per share in 12 months. Just as
Botox revolutionized the field of plastic surgery, we expect Xiaflex to create significant new growth
opportunities in underserved hand surgery and urology markets where invasive treatment is
currently the only option. MEDACorp consultants ("consultants") relate much excitement in the
medical community and significant pent-up demand for Xiaflex among patients. Accordingly, our
market model projects peak US revenue potential for Xiaflex exceeding $400MM in each of the
Dupuytren's contracture and Peyronie's disease indications. We conservatively assume penetration
only among patients who are candidates for surgery or medical therapy today and do not expand
into the watchful waiting segment. AUXL will submit the BLA for Xiaflex in Dupuytren's contracture
in 1H:09 after one-year safety data has been generated for 100 patients. We believe that FDA
approval of Xiaflex for Dupuytren's indication is relatively secure since the combination of
surgery-like efficacy with a clean safety profile should provide the FDA with a clear favorable
risk/benefit. Xiaflex fits particularly well with the agency's guidance that companies should target
niche indications for which there is unmet medical need. We are optimistic for positive clinical data
in Peyronie's disease in 4Q:09 based on a promising Phase II experience. The recent deal with
PFE for Xiaflex rights in ROW offers validation, capital, reimbursement, development and
marketing expertise that should support the opportunity. Testim has been a solid contributor to the
AUXL P&L, but we conservatively assume increased competition beginning in 4Q:09 from Endo's
(ENDP, Rated Market Perform) Nebido and/or a generic alternative. Upsher-Smith has filed a
Paragraph IV certification arguing that it would not infringe the '968 patent, which expires in 2025,
but a review of similar cases such as Sanofi vs. Par and Watson suggests that a majority of
companies file suit, resulting in a mandatory 30-month stay, and many companies settle for
arrangements including co-promotion.

VALUATION

We derive a $35 value for AUXL shares in 12 months based on a discounted cash flow (DCF)
analysis, probability-weighted to reflect the risks associated with FDA approval. We have assumed
that Xiaflex will obtain seven years of orphan drug exclusivity lasting through 2017 for Dupuytren's
contracture and through 2019 for Peyronie's disease. Our DCF has a period of intermediate growth
that culminates in a 75% reduction in sales when Xiaflex loses patent protection as an orphan drug.
Each drug and indication have been ascribed EBIT and associated costs through a revenue mix
analysis, resulting in $12/share for Xiaflex in Dupuytren's contracture, $12/share for Xiaflex in
Peyronie's disease, $6/share in Testim, $2/share for the platform, and $3/share in cash (see table
on page 3). The platform includes Xiaflex in other indications such as Frozen Shoulder Syndrome
or cellulite and the transmucosal film technology. We estimate an 90% chance of Xiaflex approval
in Dupuytren's contracture based on the robust data generated to date and a 70% chance in
Peyronie's disease given its earlier stage in clinical development. <<<

[gfp927z]

Here is Leerink Swann's analysis from 4-1-09 (re-posted from the Yahoo board) -

>>> April 1, 2009
OUTPERFORM
Reason for report:
PROPRIETARY INSIGHTS

Joseph P. Schwartz
[phone]
[e-mail]
Eric Varma, M.D.
[phone]
[e-mail]

AUXILIUM PHARMACEUTICALS

Phase III Cord Data Hasn't Shown Any IgE-Related Events with
Xiaflex

• Bottom line: A competitor downgraded AUXL from buy to sell today,
making the case that potential FDA concern about hypersensitivity upon
repeat use is underappreciated as it was for SGP's Bridion
(sugammadex) and DYAX's DX-88. We would be buyers of AUXL and
note that the competitor's analysis misses a couple important points.

• Collagenase (active ingredient in Xiaflex) already FDA-approved as
Santyl ointment for chronic dermal ulcers and severely burned tissues. If
hypersensitivity were a major concern, we believe it would be apparent in
this setting. Indeed, allergy tests routinely apply antigens to the skin in
order to test for a reaction. Yet, millions of patients with open wounds like
bedsores and diabetic ulcers have used collagenase for decades.

• Xiaflex is administered locally rather than systemically. The other
drugs that the competitor uses as examples are given IV, whereas Xiaflex
is injected directly into Dupuytren's or Peyronie's plaque lesions. Little, if
any, makes it to the systemic circulation with proper technique.

• Linking local response to a systemic hypersensitivity reaction
seems unlikely. Our competitor hypothesizes that the local pain,
tenderness, swelling, and lymphadenopathy could be related to IgE
hypersensitivity events. We believe these events are more likely related
to clearance of Xiaflex from the body and manipulation of the cord.

• We believe that the FDA won't require a repeat dosing study if
AUXL is only going for a single treatment indication. We have not
projected any repeat dosing in our model for Xiaflex in Dupuytren's or
Peyronie's disease. Worst case, we believe that the FDA would simply
write a label that says repeat use has not been studied and is not
approved in order to manage this risk.

• Importantly, the side-effect profile of Xiaflex compares very well to
the only other viable alternative of hand surgery, which is more
expensive, inconvenient, has unpredictable results and can cause
infection, complex regional pain, or anatomical damage.

• Reiterate Outperform rating on AUXL. Next up, we expect a clean
safety update for Xiaflex from the CORD studies in Dupuytren's
contracture in 1H:09 since PFE likely already vetted the database and
most AE's occur happen immediately. <<<

[gfp927z]

PDUFA date 8-28-09

Xiaflex has priority review, and as an orphan indication it will have 7 year exclusivity in the US. Auxilium has a strong partner in Europe in Pfizer. The Pfizer deal for Europe (12-08) was for $75 mil upfront, plus an additional $410 mil in milestones ($150 mil tied to regulatory milestones, and $260 mil based on commercial milestones). Royalties - tiered/increasing double digits on European sales. Auxilium owns the US rights, and various other non-European areas.

[gfp927z]

Xiaflex revenue estimates -

Here's a link to the Forbes article from 12-08 (see below). The Leerink Swann analyst estimates US revenues at $761 mil, and Europe's also at $761 mil. Combined that's over $1.5 billion. Nice.

Auxillium estimates the cost of treatment with Xiaflex to be approximately that of surgery - $5000 in the US and approx $3000 in Europe.

It is estimated that Dupuytren's Contracture affects approx 3-6% of Caucasians, especially of Northern European descent.


http://www.forbes.com/2008/12/19/auxilium-pfizer-closer-markets-equity-cx_lal_1218markets40.html?partner=yahootix

[leoncio1]

If also a moderator did not post here (some time),, ihub kicks him..

thx ihub.. a reasen more not to pay for your services..

[leoncio1]

Nice stock... nice profit so far.. lol

[leoncio1]

Hope to see a $28 break today..

[leoncio1]

Consensus Recommendations

Last Updated
Outperform December 20 Dec 2008

Analyst Recommendations and Revisions
1-5 Linear Scale Current 1 Month
Ago 2 Month
Ago 3 Month
Ago
(1) BUY 7 6 6 6
(2) OUTPERFORM 4 4 4 4
(3) HOLD 2 2 1 1
(4) UNDERPERFORM 0 0 0 0
(5) SELL 1 1 1 1
No Opinion 0 0 0 0

Mean Rating 1.86 1.92 1.83 1.83

[leoncio1]

above $28 we could see nice things.. (I believe)

Have nice weekend.. (if enyone read this.. lol)

[leoncio1]

Nice green again today, on the big $$ news..

[leoncio1]

Nice run yesterday on great news.. Hope to see more writings here..

Put some life in this I-box..

(I made Qmlm I-box) one of the best I-box I believe..

[surf1944]

14-Aug-08 Banc of America Sec Downgraded
AUXL from Buy to Neutral

[surf1944]

Fair Value on Auxilium Pharma
Thursday June 5, 2:34 pm ET
By Jason Napodano, CFA

Auxilium Pharmaceuticals Inc.'s (NasdaqGM: AUXL - News) only approved product is Testim, for treatment of low testosterone levels. It also possesses a clinical-stage candidate in Xiaflex, under development for Dupuytren's Contracture, Peyronie's Disease, and Frozen Shoulder Syndrome. The most advanced indication is for Dupuytren's Contracture which recently offered up positive data from two phase III trials.

Sales of Testim are performing above expectations and commercialization of Xiaflex represents significant upside to the investment story. We have, admittedly, underestimated Testim all throughout 2007. Based on recent data presented at the American Urological Association, we now see over 30 percent market share of Testim as achievable. However, the overall size of the testosterone-replacement market remains only around $500 million in our view, so significant growth for Testim beyond 30 percent market share is unlikely.

Given the eventual slowdown in Testim, the future of Auxilium relies heavily on the development of Xiaflex. We model Auxilium reaching profitability in 2010. The stock looks expensive at this level based on future earnings and the current price / sales [P/S] ratio. The biotech average P/S is between 7-8x, whereas Auxilium currently trades at nearly 12x. Based on our 2011 EPS forecast of $2.79, the stock is trading at 12.5x earnings. That is a premium to the peer-group, which currently trades at only 10x 2011 EPS.

The fundamentals at Auxilium are solid, but the lofty valuation keeps us from recommending the name at this level. We would be buyers of the name on a pull-back into the mid-to-high $20s. Thus, we rate the stock a Hold with a $36 target.

[surf1944]

Auxilium drug meets goal in 2 late-stage trials
Tuesday June 3, 7:45 am ET
Auxilium drug Xiaflex meets goal in 2 late-stage trials for diabetes-related hand condition

MALVERN, Pa. (AP) -- Auxilium Pharmaceuticals Inc. said Tuesday its experimental drug to treat Dupuytren's contracture, a diabetes-related condition in which fingers and the palm of the hand thicken and shorten, causing fingers to curve inward, met its goal in two late-stage trials.

Data showed that 77.8 percent of patients treated with Xiaflex saw a reduction in joint curvature, compared with 14.3 percent of patients taking placebo.

Auxilium said that out of 850 patients given Xiaflex injections in multiple trials through May 2008, seven serious adverse events possibly related to the drug have been reported. These include three tendon ruptures, one ligament injury, and one case of a serious blood clot. However, the company said the rate of the events is comparable to that involved in surgery.

The company said it plans to submit an application for approval with the Food and Drug Administration in early 2009.

more on AUXL

6:04AM Auxilium Pharma announces XIAFLEX meets primary endpoint in CORD I Ph. 3 study for Dupuytren's contracture (AUXL) 31.53 : Co announces positive top-line efficacy and safety results from the CORD I and CORD II Ph. 3 clinical trials for XIAFLEX in the treatment of Dupuytren's contracture. Each of the CORD I and II trials successfully met the primary endpoint, a reduction in the angle of a patient's joint contracture to greater than or equal to 5 degrees of normal, as measured by digital goniometry, 30 days after the last injection. Co also releases results of a Pharmacokinetic Study that demonstrate the lack of systemic exposure of XIAFLEX in patients treated for Dupuytren's contracture. The most common adverse events in the CORD I and II and PK studies were consistent with adverse events reported in previous trials and included pain, swelling, bruising and pruritis at the injection site and transient lymph node swelling and pain.




surf's up......crikey