Random Thoughts from an Organized Mind: Belviq

To put this into context, Belviq was only available three days to reach 1,087 prescriptions. It took Qsymia three weeks to get to 1,000 prescriptions. Shares of ARNA are gapping up this morning as a result. Shorts hoping for an unsuccessful Belviq commercial launch better cover now, because they are in for a rude awakening.

You know the tide is turning when Arena's former biggest basher has to report positive results.

Friday, June 14, 2013

Consumer Reports errs on Belviq

http://www.utsandiego.com/news/2013/jun/14/consumer-reports-belviq/

Thursday, June 6, 2013

Arena Pharmaceuticals, Belviq (Lorcaserin), Obesity, and BORG

Arena Pharmaceuticals weight management pill Belviq (Lorcaserin) will have its commercial launch tomorrow. It was a long, hard road to FDA approval and DEA scheduling. I am one of the proud creators and members of the BORG activist investor group, now 47 strong. There were many strong contributors, but Dr. Daniel Lopez deserves the most credit. He challenged the manufactured safety risks--and proved they were false.

The naked short hedge funds, captured media, and factions of the FDA won the battle, but we won the war. Millions of obese, overweight, and diabetics will live better lives due to Belviq. I'm certain many lives will be saved. Thank you Arena, BORG, the FDA for coming around, and the many clinicians who are treating their patients.

Obesity and its associated diseases cost this country hundreds of billion of dollars. The availability of Belviq will be a major step toward alleviating pandemic obesity.

Here is an article in the Wall Street Journal on the beginnings of BORG:

http://online.wsj.com/article/SB10001424052702304023804575566731686435318.html

By ALICIA MUNDY And JENNIFER CORBETT DOOREN
WASHINGTON—Federal regulators are set to decide the fate of a new obesity drug as soon as Friday, and with it the future of a small biotechnology company whose investors are conducting an unusually aggressive lobbying campaign to get the pill approved.

The drug, lorcaserin, made by Arena Pharmaceuticals Inc. ARNA -0.23% of San Diego, was rejected in a 9-to-5 vote by a Food and Drug Administration advisory committee in mid-September.

That prompted outrage among Arena shareholders who have spent thousands of hours on their own scientific analyses, contacted Congress, set up an online petition and flooded the FDA with comments saying the agency didn't give the diet pill a fair hearing.

It is one of a few recent cases in which individual investors in a company—not just the company itself—made their presence felt in advance of a make-or-break decision.

Arena shareholders, about 40 of whom are in an investor group nicknamed Borg, say they're raising important questions about possible bias and ignorance among the FDA panel members.

"What has mobilized so many people, within our group and beyond, are the comments and behavior of some FDA officials and what we believe to be incorrect scientific conclusions," said Douglas Park, an Arena shareholder in San Diego who used to work for the company.

Some doctors and FDA officials fear the nascent trend poses dangers to the drug-approval system.
"It's a good thing everybody is allowed to have their say, but the FDA has to do its job," said heart-disease expert Sanjay Kaul, who served as an FDA adviser and voted against lorcaserin. "This is about patients, not about money."

The FDA is due to decide on lorcaserin by Friday, although it could seek a delay. The agency usually follows the advice of its outside panelists but isn't required to do so.

Investors are showing new assertiveness because of financial uncertainty in the biotechnology business and anger at a perceived lack of predictability in FDA decisions, said former FDA Deputy Commissioner Scott Gottlieb, now a partner in a health-care investment firm.

An Arena spokesman said the company isn't involved in investor lobbying and hasn't encouraged it.

Many investors saw Arena's pill, which affects a part of the brain involved in appetite control, as safer than rival drugs. They were surprised when the FDA staff and the agency's outside advisers gave it a thumbs-down in September. FDA reviewers said lorcaserin was only modestly effective in trimming pounds and had some safety issues.

The company's stock fell 73% in the week of the vote. Arena shares declined 6.4% to $1.46 in 4 p.m. trading Thursday on the Nasdaq Stock Market.

"I got punched in the belly real bad by the FDA," said Peter Becker, a retired Army colonel in Texas. The former administrative law judge said he had bought a "very, very large position in Arena" after he spent many hours studying the safety of lorcaserin versus other diet drugs.

The backlash began quickly. One investor accosted an FDA panel member with harsh words in a hallway minutes after the Sept. 16 vote, according to people who were there. It was first reported by The HealthCare Channel digital video site.

The Borg group says the FDA understated lorcaserin's efficacy in weight loss and exaggerated safety issues.

Another investor wrote to Dr. Kaul, the panelist, politely suggesting that, "to hear the scuttlebutt going around," the panelists incorrectly assumed a risk to humans after some rats on lorcaserin developed tumors.

"Given the issues at stake here and the money invested by both ARNA [Arena] and its Stock Holders," the investor wrote, Dr. Kaul had a "responsibility to let the FDA know" that he would have voted "yes" if he fully understood the tumor issue. Dr. Kaul, based at Cedars-Sinai Medical Center in Los Angeles, says the rat issue didn't figure significantly in his vote.

The chairman of the advisory committee, Abraham Thomas of Henry Ford Hospital in Detroit, voted for the drug, but he said the shareholders are overstating what it can do.

"I could have gone either way. It's just not a very effective medication," said Dr. Thomas, who previously ran the obesity clinic at Brigham and Women's Hospital in Boston.

An FDA spokeswoman said the agency was careful in choosing panelists and reviewing drug safety and efficacy data. The FDA's meeting process was fair, she said.

One of the few precedents for the lorcaserin activism came in the fight over the prostate-cancer drug Provenge, which was rejected by the FDA in 2007. Following additional research and pressure from investors in Provenge maker Dendreon Corp., DNDN +0.64% the FDA approved Provenge in April of this year.

Several Arena shareholders said they had also invested in Dendreon, whose stock soared after the FDA approval.

Write to Alicia Mundy at alicia.mundy@wsj.com and Jennifer Corbett Dooren at jennifer.corbett-dooren@dowjones.com

Wednesday, June 5, 2013

Eisai's Coats on 2013 Sales of Arena's Obesity Drug

http://bloom.bg/15yNAkb

Monday, April 22, 2013

Mystery objectors delay weight loss drug

http://www.ft.com/intl/cms/s/0/ef3ca4ae-aa65-11e2-9a38-00144feabdc0.html#axzz2RDD5TuHr

The launch of a new weight loss drug is being held up by the US Drug Enforcement Authority, after a surge in anonymous objections that some investors fear is manipulating the process.

Belviq, developed by Arena, the US biotech company, was authorised as safe and effective by the Food and Drug Administration last June, but has yet to be ratified by the DEA under a process designed to ensure controlled use of medicines that come with a risk of abuse.

The FDA recommended that Belviq, known generically as Lorcaserin, be classified as a “schedule IV” drug, a low-risk category, which gives regulators some supervisory powers to oversee prescriptions.

But an unusually high number of 69 comments have been filed on Belviq, creating a greater workload for DEA officials in making an assessment.

The stalling has allowed Qsymia, a weight-loss drug made by Vivus, a rival US biotech, to gain a lead over Belviq, even though the drug was approved after Belviq by the FDA. While most of the 47 positive remarks on the DEA website are identified by the name of the author, 19 of 22 negative ones are anonymous, sparking debate over whether individuals with a vested interest in delaying Belviq have been posting criticisms.

Tuesday, January 15, 2013

Major Revenue Losses From Patent Expirations Forces Big Pharma Companies to Look to the Biotech Industry for Replacements

Recent analyst upgrades and articles like this have provided a boost for Arena Pharmaceutical shares.

http://finance.yahoo.com/news/major-revenue-losses-patent-expirations-132000024.html

See disclaimers in the side bar. This is not an endorsement for any company, or investment in any company.

Disclosure: the author and family members are long shares of ARNA. The author has no position in VVUS.

Wednesday, December 26, 2012

Thestreet.com reiterates Sell recommendation--Which is a contrarian signal to Buy

Adam Feuerstein is the biotech analyst at Jim Cramer's Thestreet.com. He had a Sell recommendation on Dendreon ("DNDN"), before it subsequently soared from $3 to $58 after its prostate cancer drug Provenge was approved by the FDA on April 29, 2010. (Editor's note: shares of DNDN have subsequently plummeted back to $5.28 as of today due to commercial uptake issues).

Feuerstein has also had multiple Sell recommendations on another battleground biotech company, Arena Pharmaceuticals ("ARNA"). Shares of arena have also soared from its 52-week low of $1.23 to its 52-week high of $13.50 upon FDA approval of its anti-obesity drug Belviq ("Lorcaserin"). Today, Thestreet.com reiterated a Sell recommendation on ARNA, with the shares trading around $8.72.

http://www.thestreet.com/story/11800338/1/arena-pharmaceuticals-inc-stock-sell-recommendation-reiterated-arna.html

With the benefit of hindsight, any investors listening to Thestreet.com's recommendations would have lost money--or worse, missed out on spectacular returns of more than 1000%.

Meanwhile, Thestreet.com settled Federal civil charges of accounting fraud. In typical Wall Street fashion,

TheStreet Inc. and the three executives neither admitted nor denied the allegations but agreed to refrain from future violations of the securities laws.

This outcome occurred despite these shenanigans by the company's executives:

The company filed false financial reports throughout 2008 which reported revenue from sham transactions at the subsidiary, which it acquired in 2007, the SEC said. The subsidiary conducts promotions such as sweepstakes on the Internet.

The agency said Alwine and Barnett made the phony transactions and also fabricated and backdated documents to enable the fraud.

Here is a link to the story: http://finance.yahoo.com/news/thestreet-com-company-3-executives-182033815.html;_ylt=A2KJjb3ILNtQwGgApCSTmYlQ

Meanwhile, shareholder value of Thestreet.com has plummeted over the years. Here is a price chart of TheStreet ("TST") shares from 1999 to December, 2012:

http://finance.yahoo.com/echarts?s=TST+Interactive#symbol=tst;range=my;compare=;indicator=volume;charttype=area;crosshair=on;ohlcvalues=0;logscale=off;source=undefined;

Shares have plummeted from $45 to $1.61. How this firm has been accused of and prosecuted for accounting fraud, and has consistently put out wrong directional investing recommendations, and is now trading as a penny stock--but can still stay in the business of stock-picking is beyond me. But wait--we have our answer: Jim Cramer, the clownish host on CNBC's Mad Money show is Thestreet.com's co-founder.

In hindsight, TheStreet.com should have put a Sell recommendation on itself 13 years ago. As for Thestreet.com's reiteration of a Sell recommendation for ARNA, you be the judge.