Drink your milk.
That parental edict, heard less often in recent years, had as much to do with the hectored youngster's need for vitamin D (with which the disliked cow juice was enriched), as with the importance of calcium for bone strength.
Vitamin D has related pharmaceutical uses, too, as the market was reminded in April when the FDA approved Bone Care International Inc.'s Hectorol (doxercalciferol), the pro-hormone vitamin D analogue.
Cleared in 2000 as a 2.5-mg capsule for secondary hyperparathyroidism (SHPT) in dialysis patients, the drug won more recent approval in a 0.5-mg capsule for SHPT that develops in Stages III and IV of chronic kidney disease prior to dialysis.
Hectorol is on the march. Early this month data from prescription tracker NDCHealth showed the new capsule has averaged sequential, week-to-week growth of 58 percent, with $63,000 in total prescription dollars for the week ending Nov. 19.
Since August, several analyst firms - Robert W. Baird & Co., First Albany and Roth Capital - have raised their price targets for the stock (Baird's is $29) and in November BCI joined the roster of stocks included in the Nasdaq Biotech Index.
The Madison, Wis.-based specialty pharmaceutical company, whose stock was trading at around the $25 mark, may be no Genzyme Corp. or Amgen Inc., but seems to be proving satisfactorily that it can play with the big boys. Or at least near them.
Parathyroids, of course, are neck glands that make hormone to regulate calcium in the body. Having overactive glands is known as hyperparathyroidism, and when it happens in response to low blood calcium caused by such problems as kidney trouble, it's called SHPT.
Vitamin D hormone therapy is the standard-of-care treatment for SHPT in dialysis patients, but other drugs also operate in the space. Amgen has Sensipar (cinacalcet), a small molecule partnered with NPS Pharmaceuticals Inc. and approved in March for SHPT in patients with chronic kidney disease on dialysis and for hypercalcemia in those with parathyroid carcinoma.
First-in-class oral Sensipar works by boosting sensitivity of parathyroid gland receptors to calcium levels in the bloodstream, thus lowering levels of parathyroid hormone, calcium, phosphorous and calcium-phosphorous product.
Amgen licensed calcimimetic compounds from NPS in 1996, with rights to sell the compound worldwide except in Japan, Korea, Taiwan and China, where rights to the molecule have been licensed to the pharmaceutical division of Kirin Brewery Ltd. Genzyme has Renagel (sevelamer hydrochloride), a phosphate binder for end-stage renal disease, approved in October 1998 and chalking up $281.7 million in sales last year. Joining the fray this fall was Shire Pharmaceuticals Group plc and its phosphate binder Fosrenol (lanthanum carbonate), a chewable tablet, approved for ESRD patients.
Abbott Laboratories has intravenous calcitriol under the brand name Calcijex and intravenous paricalcitol under the brand name Zemplar for ESRD patients. It is working on oral paricalcitol for pre-dialysis and dialysis patients. Intravenous versions of the drugs are approved for ESRD SHPT in the U.S. and Europe, and generic calcitriol is available.
Roche Pharmaceuticals Inc. offers Rocaltrol oral calcitriol and Teva Pharmaceuticals Inc. markets generic oral calcitriol in the U.S. to manage SHPT. The products are cleared in the U.S. for elevated parathyroid hormone in ESRD and chronic kidney disease patients, pre-dialysis.
Expand the indications or add cousin drugs and the potential competitive field broadens still more. Firms including Leo Pharmaceutical Products A/S, Teva and Chugai Pharmaceutical Company Co. Ltd. market oral or intravenous alfacalcidol, a synthetic analogue of calcitriol, in Europe and Asia under various trade names for SHPT and osteoporosis. Vitamin D hormone drugs for cancers are in development by Leo, ILEX Oncology Inc. and Chugai.
BCI and a handful of others were among those subpoenaed by the U.S. Department of Justice this fall, in an investigation that apparently has to do with practices in testing kidney patients' hormone levels.
In the company's most recent quarterly report, it said only that the subpoena "requires production of a wide range of documents relating to the operations of the company. We intend to meet with representatives from the Justice Department to discuss the scope of the subpoena and the production of responsive documents. We will cooperate with the request of the Justice Department."
Others reportedly subpoenaed include Abbott Laboratories, Renal Care Group Inc., Gambro Healthcare Inc., Quest Diagnostics Inc. and its subsidiary Nichols Institute Diagnostics, and the German firm Fresenius Medical Care.
Amid all this, Hectorol continues to find its way, thanks to the newly approved capsule as well as growth in revenue from the 2.5-mg dose. Since Oct. 1, prescription money has risen from $100,000 per week to about $200,000 per week - due to a doubling by BCI of the average wholesale price of the product.
Those numbers shouldn't be figured into the near-term big picture, though, since regulations of the Centers for Medicare and Medicaid Services require BCI make up the difference in rebates during the next year, taking away any benefit with regard to the average sales price.
Further out, though, the benefit might become clear, and BCI seems at least to have carved a niche for itself. The company upped the price on the 2.5-mg tablet to bring its yearly cost of about $1,100 more in line with what patients who get the intravenous version are paying, which is about $1,400.
Baird, which maintained an "outperform" rating on BCI stock, predicted early this month revenues of $3 million in the second fiscal quarter of next year, up from an estimated $1.7 million in the first quarter. The forecast numbers for the third and fourth quarters are $3.6 million and $4.6 million, respectively. As of Sept. 30, BCI had $63.5 million in cash and equivalents - with Hectorol apparently poised to help that upside significantly.